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30 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : "3000-03-005 FIRST FIRST-OVAIRE NCT03602859 ENGOT-0V44"
Spécialité : Gynécologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Placebo Comparator: Arm 1
Standard of care chemotherapy treatment with Dostarlimab (TSR-042) Placebo, and maintenance treatment of Niraparib 

Active Comparator: Arm 2
Standard of care chemotherapy treatment with Dostarlimab (TSR-042) Placebo, and maintenance treatment of Niraparib and Dostarlimab (TSR-042) Placebo.

Experimental: Arm 3
Standard of care chemotherapy treatment with Dostarlimab (TSR-042), and maintenance treatment of Niraparib and Dostarlimab (TSR-042).

Informations

Cancer de l'ovaire épithélial non muqueux, localement avancé ou métastatique

1ère ligne

Phase: 3

Promoteur: Tesaro
Autre(s) acronyme(s): FIRST
FIRST-OVAIRE
NCT03602859
ENGOT-0V44
Contact promoteur: EU GSK Clinical Trials Call Center
Mail promoteur:
Contact: GSKClinicalSupportHD@gsk.com

Tel promoteur: 44 (0) 20 89904466

-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

ENGOT-0V44 The FIRST (First-line Ovarian Cancer Treatment With Niraparib Plus TSR-042) Study: A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Critères d'inclusion :
  1. Patients with a histologically confirmed diagnosis of high-grade nonmucinous epithelial ovarian (serous, endometrial, clear cell, carcinosarcoma, an mixed pathologies), fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria.

  2. All patients with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo primary debulking surgery (complete cytoreduction (CC0) or macroscopic disease), or those for whom neoadjuvant chemotherapy is planned.

  3. Patients with Stage III are eligible if they meet one or more of the following criteria:

    High risk Stage IIIC disease.

    Planning to receive neoadjuvant chemotherapy.

  4. Patients must provide a blood sample for research at Screening.

  5. Patient must provide sufficient tumor tissue sample (a minimum of 2 formalin-fixed paraffin embedded blocks) at Screening for research.

  6. Patients must have adequate organ function (Note: complete blood count test should be obtained without transfusion or receipt of stimulating factors within 2 weeks before obtaining Screening blood sample)

  7. Patients must have an ECOG score of 0 or 1.

  8. Patients must have normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP ≤140 mmHg and/or diastolic BP ≤90 mmHg).

  9. Patients must agree to complete HRQoL questionnaires throughout the study.

  10. Patients must be able to take oral medication.

Critères de non-inclusion :
  1. Patient has mucinous, germ cell, transitional cell, or undifferentiated tumor.

  2. Patient has low-grade or Grade 1 epithelial ovarian cancer.

  3. Stage III patient with complete cytoreduction (CC0) resection after primary debulking surgery (ie, no macroscopic residual disease, unless the patient has aggregate 5 cm extra-pelvic disease during primary debulking surgery.

  4. Patient has not adequately recovered from prior major surgery.

  5. Patient has a known condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment in the opinion of the Investigator.

  6. Patient has been diagnosed and/or treated with any therapy for invasive cancer <5 years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy (eg, trastuzumab) less than 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment. Patients with definitively treated non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, Grade 1 or 2, Stage IA endometrial cancer, or non-melanomatous skin cancer are allowed.

  7. Patient is at increased bleeding risk due to concurrent conditions (eg, major injuries or major surgery within the past 28 days prior to start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).

  8. Patient is immunocompromised. Patients with splenectomy are allowed. Patients with well-controlled known human immunodeficiency virus (HIV) are allowed.

  9. Patient has known active hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] is detected).

  10. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection.

  11. Patient has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.

  12. Patient has received a live vaccine within 14 days of planned start of study therapy. Seasonal influenza vaccines that do not contain live viruses are allowed.

  13. Patient has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, dostarlimab, or their excipients.

  14. Prior treatment for high-grade nonmucinous epithelial ovarian, fallopian tube, or peritoneal cancer (immunotherapy, anti-cancer therapy, radiation therapy).

  15. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (eg, thyroid hormone or insulin).

  16. Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Thibault de la MOTTE-ROUGE - Oulimata Diop - o.diop@rennes.unicancer.fr nc / nc Oui 28/01/2020
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr 3 / NC Oui 28/01/2020
Afficher les détails
Acronyme : "ALBAN UC-0160/1717 NCT03799835 "
Spécialité : Urologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Active Comparator: Arm A : control arm
BCG therapy only

BCG therapy will be administered in two phases:

induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).

Experimental: Arm B: experimental arm
BCG therapy + administration of atezolizumab

BCG therapy will be administered in two phases:

induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).

Informations

Cancer de la vessie non infiltrant haut risque, adjuvant

Phase: 3

Promoteur: UNICANCER
Autre(s) acronyme(s): UC-0160/1717
NCT03799835
Contact promoteur: Soazig Nénan-Le Ficher
Maggy Chausson
Mail promoteur: s-nenan@unicancer.fr
m-chausson@unicancer.fr

Tel promoteur: 33185343113
33185343112 ou 33185343112

-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Titre :

An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer

Critères d'inclusion :
  1. Signed informed consent form

  2. Adult man and women ( age ≥18 years)

  3. Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed histology tumors allowed if urothelial carcinoma histology is predominant) defined on the TURBT as any of the Following :

    T1 tumor and/or

    High grade (G3) and/or

    Carcinoma in situ (CIS)

  4. Tumor tissue available from the surgery for central confirmation of the diagnosis and analysis the expression of PD-L1

  5. At least one additional (second) resection of the primary tumor has been performed in case of T1 tumors, or incomplete initial TURB, or in case of doubt about completeness of a TURB, or if there is no muscle in the specimen (can be omitted if TaLG/G1 tumors or primary CIS only was found) without upstaging towards MIBC (EAU guidelines, 2017)

  6. Absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 42 days prior to the first study treatment

  7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

  8. Life expectancy ≥12 weeks

  9. Systolic blood pressure (BP) <160 mmHg and diastolic BP <95 mmHg, as documented within 7 days prior to the first study treatment (hypertension allowed provided it is controlled)

  10. Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 7 days prior to the first study treatment:

    absolute neutrophil count (ANC) ≥1500 cells/μL

    white blood cell (WBC) counts >2500/μL

    Lymphocyte count ≥300/μL

    Platelet count ≥100,000/μL

    Hemoglobin ≥9.0 g/dL

    aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and alkaline phosphatase ≤2.5 × the upper limit of normal (ULN)

    Serum bilirubin ≤1.0 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.

    Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or international normalized ratio (INR) <1.7 × ULN

    Calculated creatinine clearance ≥20 mL/min (Cockcroft-Gault formula)

  11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab

  12. Patients affiliated to the social security system

  13. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up

Critères de non-inclusion :
  1. Patient having received previous BCG therapy for bladder cancer

  2. Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment. Hormone-replacement therapy or oral contraceptives are authorized

  3. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to day 1 of study treatment

  4. Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of treatment except the following:

    Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent and without prostate-specific antigen (PSA) recurrence are eligible.

    Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤7 and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.

    Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years) are eligible provided they meet all of the following criteria: malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) and no evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.

  5. Pregnancy or breastfeeding

  6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

  7. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

  8. History of autoimmune disease or history of immunosuppression, or conditions associated with congenital or acquired immune deficiency , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases)

    Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.

    Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.

    History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan may be eligible.

    History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

  9. Serum albumin <2.5 g/dL

  10. Known HIV infection

  11. Patients with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen (HBsAg) test at screening) or hepatitis C.

    Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomisation.

    Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

  12. Known active tuberculosis

  13. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

  14. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1

  15. Receipt of therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.

  16. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina.

    - Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.

  17. Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study

  18. Prior allogeneic stem cell or solid organ transplant

  19. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation if such a live, attenuated vaccine will be required during the study

    - Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1, at randomization, during treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab).

  20. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

  21. Prior treatment with CD137 agonists or immune checkpoint−blockade therapies, including anti-CD40, anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies

  22. Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin 2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1

  23. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial

    Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study.

    The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.

  24. Person deprived of their liberty or under protective custody or guardianship

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr MATHIEU - UIC - NC / NC Oui 31/01/2020
Plérin - CARIO - HPCA Dr BESSON/Dr CORBEL - - NC / NC Oui 10/10/2019
Afficher les détails
Acronyme : "BI12800.18 1280.18 NCT03099174 ""BI12800.18 1280.18 NCT03099174 "
Spécialité : Gynécologie - Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Experimental: Cohort A
Xentuzumab + Abemaciclib (Dose 1)

Experimental: Cohort B
Xentuzumab + Abemaciclib + Letrozole (Dose 2)

Experimental: Cohort C
Xentuzumab + Abemaciclib + Anastrozole (Dose 3)

Experimental: Cohort D
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Experimental: Cohort E
Xentuzumab + Abemaciclib (Dose 1)

Experimental: Cohort F
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Experimental: Cohort D1
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Experimental: Cohort D2
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Informations

 

Cancer du sein, avancé, métastatique

 

Phase: 1

Promoteur: Boehringer Ingelheim
Autre(s) acronyme(s): 1280.18
NCT03099174

Contact promoteur: Boehringer Ingelheim Call Center
Mail promoteur: clintriage.rdg@boehringer-ingelheim.com
Tel promoteur: 1-800-243-0127
-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Titre :

An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.

Critères d'inclusion :

Cohort A (Solid Tumours)

  1. Age >= 18 years (>=20 years for Japan only) at screening

  2. Signed and dated written informed consent in accordance with GCP (Good Clinical Practice and local legislation prior to admission to the trial

  3. WHO/ECOG (World Health Organization / Eastern Cooperative Oncology Group) performance status 0-1 assessed at screening

  4. Patient must be able to swallow oral capsules.

  5. Male or female patients ready and able to use highly effective methods of birth control during the study and for 3 weeks following the last dose of abemaciclib per ICH (International Conference on Harmonization) M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Women of childbearing potential must have a negative serum pregnancy test at screening.

  6. Patients with histologically or cytologically confirmed diagnosis of advanced and/or metastatic, measurable or evaluable, non-resectable solid tumours

  7. Patients must have received and failed, or have been intolerant to, all treatment known to confer clinical benefit or have no therapeutic options available as deemed appropriate by their treating physician

  8. Life expectancy >= 3 months in the opinion of the investigator assessed at screening;

Cohorts B, C, D, F (Breast Cancer):

  1. Age >= 18 years (>=20 years for Japan only) at screening

  2. Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial

  3. WHO/ECOG performance status 0-1 assessed at screening

  4. Patient must be able to swallow oral capsules.

  5. Women who have postmenopausal status due to either surgical/natural menopause or chemical ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin or radiation-induced ovarian suppression.

  6. postmenopausal status due to surgical/natural menopause requires at least one of the following conditions:

  7. prior bilateral oophorectomy

  8. age ≥ 60 years

  9. age < 60 years and amenorrheic (in the absence of tamoxifen,toremifene, ovarian suppression, or chemotherapy) for at least 12 months; and follicle-stimulating hormone (FSH) and estradiol within the postmenopausal range as per institutional reference ranges.

  10. Postmenopausal status due to radiation-induced ovarian suppression must be confirmed by FSH and estradiol level in the postmenopausal range

  11. Histologically or cytologically proven diagnosis of breast cancer with evidence of locally advanced disease not amenable to curative resection or metastatic disease

  12. HR+ (local lab results at screening or, if not available, at the time of diagnosis) To fulfil the requirement of HR+ disease, the primary tumour or metastatic lesion of the breast cancer must express at least one of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PgR]) by immunohistochemistry (IHC). Estrogen receptor and PgR assays are considered positive if there are at least 1% positive tumour nuclei in the sample as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines (Hammond et al. 2010).

  13. HER2 negative (local lab results at screening or, if not available, at the time of diagnosis) as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines (Hammond et al. 2010).

  14. Previous adjuvant and neoadjuvant chemotherapy is permitted. 0-2 prior lines of chemotherapy for the metastatic setting are allowed.

  15. At least 1 lesion (measurable or non-measurable) that can be accurately assessed at baseline with CT or MRI or PET-CT (CT portion of diagnostic quality) and which is suitable for accurate repeated measurement. For Cohort F only: patients should have at least one measurable lesion.

Cohort B, C, D, F Must be eligible for the corresponding hormonal therapy (letrozole, anastrozole or fulvestrant). For Cohorts B and C previous treatment with fulvestrant or exemestane is allowed. For Cohort D and F prior therapy with non steroidal aromatase inhibitors (anastrozole, letrozole) or exemestane are permitted

Cohort F only: Postmenopausal with locally advanced or metastatic HR+ breast cancer and refractory to aromatase inhibitors therapy and CDK4/6 inhibitor treatment (e.g., palbociclib or ribociclib) for locally advanced or metastatic breast cancer.Resistance to aromatase inhibitors therapy is defined as the following:

  1. disease recurrence while on, or within 12 months of end of adjuvant treatment with letrozole, anastrozole, or exemestane;

  2. or disease progression while on, or within one month of end of letrozole, anastrozole, or exemestane.

  3. Cohort E (NSCLC (Non-Small Cell Lung Cancer)):

  4. Age >= 18 years (>=20 years for Japan only) at screening

  5. Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial

  6. WHO/ECOG performance status 0-1 assessed at screening

  7. Patient must be able to swallow oral capsules.

  8. Male or female patients ready and able to use highly effective methods of birth control during the study and for 12 weeks following the last dose of abemaciclib per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Women of childbearing potential must have a negative serum pregnancy test at screening.

  9. Histologically or cytologically confirmed diagnosis of stage IV NSCLC.

  10. The participant must have progressed after platinum-based chemotherapy AND immunotherapy (unless deemed inappropriate candidates for immunotherapy by their treating physician) AND have received a maximum of 2 other prior chemotherapy for advanced and/or metastatic disease OR must be judged by the physician as ineligible for further standard second-line chemotherapy. Prior treatment with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) and anaplastic lymphoma kinase (ALK) inhibitors is mandatory in participants whose tumour has EGFR-activating mutations or ALK translocations. Prior targeting agents and neoadjuvant/adjuvant therapies are permitted.

  11. Have adequate organ function including haematology, renal, and liver.

  12. Have measureable disease per Response Evaluation Criteria In Solid Tumours (RECIST) 1.1.

  13. Further inclusion criteria apply

Critères de non-inclusion :
  1. Cohorts A, B, C, D (dose finding), E and F:

  2. Any documented active or suspected malignancy or history of malignancy, other than the disease under study, within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix or ductal carcinoma in situ (DCIS) if properly treated in opinion of the investigator.

  3. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial

  4. Previous treatment in this trial

  5. Currently enrolled in another investigational device or drug study, or less than 21 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).

  6. Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable study subject or unlikely to complete the trial

  7. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Men who plan to father a child while in the trial.

  8. Prior anti-cancer chemotherapy, biological or radiation therapy, androgens, thalidomide, other anticancer agents, or any investigational drug within 21 days (14 days for nonmyelosuppressive agents); and/or 4 weeks for immunotherapy, before starting any of the trial drugs.

  9. Prior anti CDK (Cyclin-dependent Kinase) agents (except cohort F)

  10. Prior radiotherapy to >= 25% of bone marrow regardless of when it was received

  11. Unresolved treatment related toxicity from previous therapy of > CTCAE grade 1 at study entry (except for stable sensory neuropathy ≤ CTCAE grade 2 and alopecia)

  12. Previous treatment with IGF (Insulin-like Growth Factor)-1R targeting compounds

  13. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease, as indicated by clinical symptoms, cerebral oedema, and/or progressive growth. History of CNS metastases or cord compression are eligible if they have been definitively treated (e.g. radiotherapy, stereotactic surgery) and are clinically stable, off anticonvulsants and steroids for at least 4 weeks. Patients with brain metastases are eligible if they are asymptomatic, completed radiotherapy for at least 4 weeks or are on a stable dose of steroids for at least 4 weeks. Patients are not eligible if they have spinal cord compression.

  14. Any evidence of severe or uncontrolled systemic disease as judged by the Investigator.

  15. Inadequate bone marrow reserve or organ function as demonstrated by any of the following: ANC < 1.5 x 109/L, platelets < 100 x 109/L, haemoglobin <90g/L, ALT > 2.5 x ULN or > 5 x ULN in the presence of liver metastases, total bilirubin >1.5 x ULN or >3 x ULN in patients with Gilbert's Syndrome, serum creatinine > 1.5 x ULN concurrent with creatinine clearance <= 50 mL/min.

  16. Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis

  17. Refractory nausea and vomiting, chronic GI diseases, inability to swallow the product, or previous significant bowel resection that would preclude adequate absorption of abemaciclib or resulting in baseline Grade 2 or higher diarrhoea.

  18. History of hypersensitivity to active or inactive excipients of xentuzumab, abemaciclib or letrozole/anastrozole/fulvestrant, or loperamide hydrochloride, or drugs with similar chemical structures

  19. Patients with Diabetes Type I or uncontrolled Type II (defined by HgBA1C > 8%)

  20. Patients with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short term including patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% of liver involvement in metastases.

  21. Prior hematopoietic stem cell or bone marrow transplant

  22. Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Subjects with controlled atrial fibrillation for >30 days prior to study treatment are eligible.

  23. Erythropoietin, G-CSF, and GM-CSF are not allowed within 2 weeks prior to study. The primary prophylactic use of G-CSF is not permitted but it may be used to treat treatment emergent neutropenia.

  24. Have had major surgery (excluding biopsy) < 28 days of the initial dose of any of the study drugs or planned major surgery during study participation.

  25. Have active bacterial or fungal infection (that is, requiring IV antibiotics or therapy at time of initiating study treatment), and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen, or hepatitis C antibodies). Screening is not required for enrolment.

  26. Patients with baseline Grade >=2 hyperglycaemia or patients with baseline Grade >= 2 diarrhoea

  27. Patients needing treatment with CYP3A4 inhibitors/inducers cannot be included in the trial.

  28. Further exclusion criteria apply

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr NC / NC Oui 02/10/2019
Afficher les détails
Acronyme : "DS8201-A-U301 DESTINY-Breast02 NCT03523585 2018-000221-31 ( EudraCT Number ) 184017 ( Registry Identifier: JAPIC CTI )"
Spécialité : Gynécologie - Sénologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Trastuzumab deruxtecan (DS-8201a)
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
Intervention: Drug: Trastuzumab deruxtecan
Active Comparator: Trastuzumab+capecitabine
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine

Active Comparator: Lapatinib+capecitabine
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine

Informations

Phase: 3

Promoteur: Daiichi Sankyo, Inc
Autre(s) acronyme(s): DESTINY-Breast02
NCT03523585
2018-000221-31 ( EudraCT Number )
184017 ( Registry Identifier: JAPIC CTI )
Contact promoteur: Daichi
Mail promoteur: dsclinicaltrial@daiichisankyo.co.jp
Tel promoteur: 81-3-6225-1111

-
Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies,

Critères d'inclusion :
  1. Is the age of majority in their country

    Has pathologically documented breast cancer that:

    is unresectable or metastatic

    has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory

  2. was previously treated with ado-trastuzumab emtansine (T-DM1)

  3. Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)

  4. Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.

  5. Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:

    5 months after the last dose of DS-8201a

    6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)

    7 months after the last dose of trastuzumab/capecitabine

  6. Has adequate hematopoietic, renal and hepatic functions

Critères de non-inclusion :
  1. Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo

  2. Has had prior treatment with capecitabine

  3. Has uncontrolled or significant cardiovascular disease

  4. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening

  5. Has active central nervous system (CNS) metastases

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan Dr H. Simon - - NC / NC Oui 22/11/2019
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - - NC / NC Oui 18/06/2019
Rennes - Centre Eugène Marquis Dr C. Perrin - - NC / NC Oui 31/12/2019
Afficher les détails
Acronyme : "DS8201-A-U303 DESTINY-Breast04 2018-003069-33 ( EudraCT Number ) 184223 ( Registry Identifier: JAPIC CTI ) NCT03734029"
Spécialité : Gynécologie - Sénologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: DS-8201a
DS-8201a is administered as an intravenous (IV) infusion every 21 days (Q3W), initially for at least 90 minutes, then, if there is no infusion-related reaction, for a minimum of 30 minutes thereafter.
Intervention: Drug: Trastuzumab deruxtecan (DS-8201a)
Active Comparator: Physician's Choice
Physician's choice comparative therapy will be administered in accordance with the locally approved label. The physician's choice is predefined, prior to randomization, from the following options:

Capecitabine
Eribulin
Gemcitabine
Paclitaxel
Nab-paclitaxel
Interventions:
Drug: Capecitabine
Drug: Eribulin
Drug: Gemcitabine
Drug: Paclitaxel
Drug: Nab-paclitaxe

Informations

Cancer du sein HER low (1+, 2+/ISH-), inopérable, métastatique

2ème ou 3ème ligne

La cohorte "HR négatif" est fermée aux inclusions

Phase: 3

Promoteur: Daiichi Sankyo, Inc
Autre(s) acronyme(s): DESTINY-Breast04
2018-003069-33 ( EudraCT Number )
184223 ( Registry Identifier: JAPIC CTI )
Contact promoteur:
Daichi
Mail promoteur: dsclinicaltrial@daiichisankyo.co.jp
Tel promoteur: 81-3-6225-1111

-
Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Critères d'inclusion :
  1. Is the age of majority in their country

  2. Has pathologically documented breast cancer that:

    Is unresectable or metastatic

    Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)

    Is HR-positive or HR-negative

    Has progressed on, and would no longer benefit from, endocrine therapy

    Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the metastatic setting

  3. Has documented radiologic progression (during or after most recent treatment)

  4. Has adequate tumor samples available or is wiling to provide fresh biopsies prior to randomization for:

    assessment of HER2 status

    assessment of post-treatment status

  5. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

  6. Has at least 1 protocol-defined measurable lesion

  7. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions

  8. If of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels

Critères de non-inclusion :
  1. Is ineligible for all options in the physician's choice arm

  2. Has breast cancer ever assessed with high-HER2 expression

  3. Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate

  4. Has uncontrolled or significant cardiovascular disease

  5. Has spinal cord compression or clinically active central nervous system metastases

  6. Has history, current, or suspicion of interstitial lung disease/pneumonitis

  7. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan Dr H. Simon - - / Oui 07/02/2020
ANGERS - Institut de Cancérologie de l'Ouest Dr FRENEL Jean Sebastien - - / Oui 07/02/2020
Rennes - Centre Eugène Marquis Dr Claudia Lefeuvre - - NC / NC Oui 07/02/2020
NANTES - Institut de Cancérologie de l' Ouest FRENEL Jean Sébastien - - NC / NC Oui 07/02/2020
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - - NC / NC Oui 07/02/2020
Afficher les détails
Acronyme : "IMpassion030 WO39391 2016-003695-47 BIG 16-05 AFT-27 ALEXANDRA NCT03498716"
Spécialité : Gynécologie - Sénologie
Traitement : Chimiothérapie adjuvante
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Atezolizumab + Chemotherapy
Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose
Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Active Comparator: Chemotherapy
Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Informations

Cancer du sein triple négatif,

opérable, non métastatique : stade 2, stade 3

1ère ligne adjuvant

Phase: 3

Promoteur: ROCHE / Breast International Group / Alliance Foundation Trials (AFT) / Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU) / Frontier Science and Technology Research Foundation Inc (FS)

Autre(s) acronyme(s): IMpassion030 WO39391
2016-003695-47/ BIG 16-05 / AFT-27 / ALEXANDRA

Contact promoteur: Roche Reference Study ID Number: WO39391
Mail promoteur: global-roche-genentech-trials@gene.com
Tel promoteur: 888-662-6728

-
Source: Clinical trials.gov janvier 2019

Cet essai dans d'autres annuaires :

Titre :

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

Critères d'inclusion :
  1. Non-metastatic operable Stage II-III breast cancer

  2. Histologically documented TNBC (Triple Negative Breast Cancer)

  3. Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen

  4. Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy

  5. Adequate hematologic and end-organ function

  6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures

  7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.

  8. No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.

  9. Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.

Critères de non-inclusion :
  1. Prior history of invasive breast cancer

  2. For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.

  3. Previous therapy with anthracyclines or taxanes for any malignancy

  4. Cardiopulmonary dysfunction

  5. Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome

  6. Active or history of autoimmune disease or immune deficiency

  7. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

  8. Urinary outflow obstruction

  9. Active tuberculosis

  10. Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)

  11. Prior allogeneic stem cell or solid organ transplant

  12. Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Lorient - Centre Hospitalier Bretagne Sud Dr O. LUYCX - Nolwen Leissen - n.leissen@ch-bretagne-sud.fr

Tel: 02.97.06.74.61

NC / NC Oui 21/02/2020
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr NC / NC Oui 30/09/2019
Quimper - CHI Cornouaille Dr. Mollon - Pascaline Rameau - p.rameau@ch-cornouaille.fr NC / NC À venir 09/01/2019
Afficher les détails
Acronyme : "PANIRINOX UCGI 28 PANIRINOX 2016-001490-33 "
Spécialité : Digestif
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: A=Experimental group
FOLFIRINOX + Panitumumab oxaliplatin 85mg/m² IV infusion over 2 hours immediately followed by folinic acid 400mg/m² given as a 2-hour IV infusion with the addition, after 30 minutes of irinotecan 150mg/m² given as a 90-minute intravenous infusion through a Y-connector immediately followed by fluorouracil 400mg/m² IV bolus then 5-FU 2400 mg/m² over 46 hours continuous infusion.


Active Comparator: B=Control group
mFOLFOX6 + Panitumumab mFOLFOX6 every 2 weeks: oxaliplatin 85mg/m² IV infusion over 2 hours immediately followed by folinic acid 400mg/m² IV infusion over 2 hours followed by fluorouracil 400mg/m² IV bolus then 5-FU 2400mg/m² over 46 hours continuous infusion.

Informations

Cancer colorectal métastatique

(K-RAS, N-RAS, B-RAF sauvage déjà déterminés)

1ère ligne métastatique (exclus: patient ayant recu de l'oxaliplatin en adjuvant)

"Phase: 2

Promoteur: Unicancer
Acronymes: PANIRINOX
UCGI 28 PANIRINOX
2016-001490-33
Contact promoteur: Sandra PELISSIER

Mail promoteur: s-pelissier@unicancer.fr
Tel promoteur: 33 1 44 23 55 68
-
Source: https://clinicaltrials.org 19/10/17

Cet essai dans d'autres annuaires :

Titre :

Study Comparing FOLFIRINOX + Panitumumab Versus mFOLFOX6 + Panitumumab in Metastatic Colorectal Cancer Patients Selected by RAS and B-RAF Status From Circulating DNA Analysis

Critères d'inclusion :
  1. Age between 18 and 75 years

  2. ECOG PS between 0 and 1

  3. Histologically confirmed adenocarcinoma of the colon or rectum

  4. Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent

  5. K-Ras (codons 12, 13, 59, 61, 117, 146), N-Ras (codons 12, 13, 59, 61) and B-Raf (codon 600) wild-type tumor status according to plasma analysis of circulating cell free DNA by Intplex technology

  6. Measurable disease according to RECIST version 1.1

  7. Adequate hematologic, hepatic and renal functions:

    Absolute neutrophil count (ANC) ≥2 x 109/L

    Haemoglobin ≥9 g/dL

    Platelets (PTL) ≥100 x 109/L

    AST/ALT ≤5 x ULN

    Alkaline phosphatase ≤2.5 x ULN

    Bilirubin ≤1.5 x ULN

    Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula)

  8. Life expectancy of at least 3 months

  9. Adequate contraception if applicable

  10. Patient affiliated to a social security regimen

  11. Patient information and signed written consent form

Critères de non-inclusion :
  1. History of other malignancy within the previous 5 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)

  2. Adjuvant treatment with oxaliplatin

  3. Previous treatment for metastatic disease

  4. Patients who received any chemo- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test

  5. Brain metastases

  6. Patients with a history of severe or life-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study

  7. Patient with history of pulmonary fibrosis or interstitial pneumonitis

  8. Previous organ transplantation, HIV or other immunodeficiency syndromes

  9. Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, inflammatory bowel disease, intestinal obstruction, symptomatic congestive heart failure, uncontrolled hypertension…)

  10. Persistent peripheral neuropathy >grade1 (NCI CT v4.03)

  11. Ionic disorders as:

    Kalemia ≤1 x ULN

    Magnesemia <0.5mmol/L

    Calcemia <2mmol/L

  12. Patient with known dihydropyrimidine dehydrogenase deficiency

  13. QT/QTc>450msec for men and >470msec for women

  14. Patient with contraindication for trial drugs (investigators have to refer to SmPC drugs, see Appendix 7)

  15. Concomitant intake of St. John's wort

  16. Other concomitant cancer

  17. Patient participating another clinical trial

  18. Pregnant woman or lactating woman

  19. Patients with psychological, familial, sociological or geographical condition hampering compliance with the study protocol and follow-up schedule

  20. Legal incapacity or limited legal capacity

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Martin-Barbau - Aude Vincent - a.vincent@bec22.fr / Oui 28/11/2019
Afficher les détails
Acronyme : "PATINA PATINA-Sein NCT02947685 AFT-38 "
Spécialité : Gynécologie - Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Arm A
Palbociclib 125 mg daily + AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt) until confirmed disease progression
Interventions:


Active Comparator: Arm B
AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant) until confirmed disease progression

Informations

Cancer du sein, métastatique, HER2+ RO+ et/ou RP+ +/-CT (néo) adj mais métastases >6 mois

1ère ligne

 

Phase: 3

Promoteur: Alliance Foundation Trials, LLC.
Autre(s) acronyme(s): PATINA-Sein
NCT02947685
AFT-38

Contact promoteur: Jane S Lanzillotti, MS

Mail promoteur: patina@alliancefoundationtrials.org 

Tel promoteur: (617) 732-8727

-
Source: Clinical Trial"

Cet essai dans d'autres annuaires :

Titre :

A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

Critères d'inclusion :
  1. Signed Preliminary Screening Informed Consent Form obtained prior to any study specific assessments and procedures

  2. Age ≥18 years (or per national guidelines)

  3. Participants must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent. Histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer.

  4. Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines.

  5. Patients must agree to provide a representative formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) from primary breast or metastatic site (archival) OR at least 15 freshly cut unstained slides from such a block, along with a pathology report documenting HER2 positivity and hormone receptor positivity.

  6. Patients should be willing to provide a representative tumor specimen obtained from metastatic disease if clinically feasible. This is a recommended but optional research biopsy.

    Inclusion Criteria (Randomization Screening)

  7. Signed Main Informed Consent Form obtained prior to any study specific assessments and procedures

  8. Age ≥ 18 years (or per national guidelines)

  9. ECOG performance status 0-1

  10. Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.

  11. Serum or urine pregnancy test must be negative within 7 days of randomization in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential and male patients randomized into the study must use adequate contraception for the duration of protocol treatment and for 6 months after the last treatment with palbociclib if they are in Arm A and for 7 months after last treatment with trastuzumab if in either Arm A or Arm B Adequate contraception is defined as one highly effective form (i.e. abstinence, (fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository).

  12. Resolution of all acute toxic effects of prior induction anti-HER2-based chemotherapy regimen to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion) 12 weeks between last dose of chemotherapy-anti-HER2therapy and randomization are allowed. Endocrine therapy could start before study randomization.

  13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

    Prior Treatment Specifics

  14. Patients may or may not have received neo/adjuvant therapy, but must have a disease-free interval from completion of anti-HER2 therapy to metastatic diagnosis ≥6 months.

  15. Patients must have received an acceptable, standard, chemotherapy containing anti-HER2 based induction therapy for the treatment of metastatic breast cancer prior to study enrollment. For this study, chemotherapy is limited to a taxane or vinorelbine (only for trastuzumab-based regimen). Eligible patients are expected to have completed 6 cycles of chemotherapy containing anti-HER2-therapy treatment. A minimum of 4 cycles of treatment is acceptable for patients experiencing significant toxicity associated with treatment as long as they are without evidence of disease progression (i.e. CR, PR or SD). The maximum number of cycles is 8. Patients can randomize immediately following completion of their induction therapy, or for those who have already completed induction, a gap of 12 weeks between their last infusion/dose of induction therapy and the C1D1 visit is permitted. Patients are eligible provided they are without evidence of disease progression by local assessment (i.e. CR, PR or SD).

  16. Participants with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:

    Disease outside the CNS is present.

    No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study

    No history of intracranial hemorrhage or spinal cord hemorrhage

    Not requiring anti-convulsants for symptomatic control

    Minimum of 3 weeks between completion of CNS radiotherapy and Cycle 1 Day 1 and recovery from significant (Grade ≥ 3) acute toxicity with no ongoing requirement for corticosteroid

    Baseline Body Function Specifics

  17. Absolute neutrophil count ≥ 1,000/mm3

  18. Platelets ≥ 100,000/mm3

  19. Hemoglobin ≥ 10g/dL

  20. Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.

  21. Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 × institutional ULN (≤5 x ULN if liver metastases are present).

  22. Serum creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

  23. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO or MUGA

Critères de non-inclusion :
  1. Concurrent therapy with other Investigational Products.

  2. Prior therapy with any CDK 4/6 inhibitor.

  3. History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.

  4. Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization (see Section 8.6.3 for list of strong inhibitors or inducers of CYP3A isoenzymes).

  5. Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation.

  6. Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry.

  7. Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are ineligible because of the potential for pharmacokinetic interactions or increased immunosuppression with palbociclib.

  8. QTc interval >480 msec, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.

  9. Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr NC / NC Oui 01/10/2019
Rennes - Centre Eugène Marquis Dr Claudia Lefeuvre - Oulimata Diop - o.diop@rennes.unicancer.fr NC / NC Oui 06/08/2019
Afficher les détails
Acronyme : "UTOLA GINECO-EN-104b NCT03745950"
Spécialité : Gynécologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif


The Olaparib arm :

Patients will be administrated the randomized study treatment tablets orally at a dose of 300 mg twice daily until objective radiological disease progression as per RECIST (Response evaluation criteria in solid tumors) as assessed by the investigator, or unacceptable toxicity

The placebo arm :

Patients will be administrated the randomized study treatment tablets orally at a dose of 300 mg twice daily until objective radiological disease progression as per RECIST as assessed by the investigator, or unacceptable toxicity

 

Informations

Carcinome avancé de l'endomètre, sensible au platine

2ème ligne

Phase: 2

Promoteur: ARCAGY GINECO
Autre(s) acronyme(s): GINECO-EN-104b
NCT03745950
Contact promoteur: Aurélie MORVAN
Mail promoteur: amorvan@arcagy.org
Tel promoteur: 33(1)42348323

-
Source: Clinical Trial

Cet essai dans d'autres annuaires :

Titre :

Multicenter Double Blind Randomized Phase II Trial of Olaparib vs Placebo as Maintenance Therapy in Platinum-sensitive Advanced Endometrial Carcinoma

Critères d'inclusion :
  1. Female Patient ≥18 years at the day of consenting to the study

  2. Provision of informed consent prior to any study specific procedures

  3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status < 2

  4. Patient with advanced/metastatic endometrial cancer not candidate to a curative treatment with surgery or radiotherapy

  5. Patients who have completed prior to randomization one Platine based chemotherapy for advanced disease after 6 cycles of chemotherapy (at least 4 cycles of platine). Patients must have a measurable disease according RECIST 1-1 at the initiation of the chemotherapy (cf. appendix 3)

  6. Patients must be prior to randomization without evidence of disease (NED) or in complete response (CR) or partial response (PR) or stable disease from the chemotherapy

  7. Patient should have been tested biolology for IHC : P53 and MMR within two weeks before the randomisation and (NGS; BRCA/HRD) within 3 months after the randomisation

  8. Patients could have been previously treated with Hormone-therapy

  9. Adjuvant chemotherapy or local radio-chemotherapy is allowed (with a delay of at least of 12 months). First recurrence at least 12 months after a loco-regional treatment.

  10. Patients pay have received external beam +/- vaginal brachytherapy

  11. All histologic and molecular subtypes of endometrial carcinoma will be included (including mixte histology), except carcinosarcoma, neuro-endocrine and small cells carcinoma.

  12. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:

    Haemoglobin ≥10.0 g/dL with no blood transfusion in the past 28 days

    Absolute neutrophil count (ANC) ≥1.5 x 109/L

    Platelet count ≥100 x 109/L

    Total bilirubin ≤1.5 x institutional upper limit of normal (ULN)

    Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤5x ULN

    Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min:

  13. Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or CTCAE G 1, except for alopecia (any grade) and ≤ G 2 sensory peripheral neuropathy

  14. Able to swallow and retain oral drug

  15. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. (negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as: Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments/Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50/radiation-induced oophorectomy with last menses >1 year ago/chemotherapy-induced menopause with >1 year interval since last menses/surgical sterilisation (bilateral oophorectomy or hysterectomy)"

  16. Life expectancy > 16 weeks

  17. Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.

  18. As this study will include patients in France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category.

  19. For inclusion in ancillary studies If a patient declines to participate in the optional Biomarker/pharmacogenetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study

Critères de non-inclusion :
  1. Patients with carcinosarcoma, neuro-endocrine and small cells histologies

  2. Patients who have previously received more than 1 line of chemotherapy for advanced/metastatic endometrial cancer

  3. Patients with a localized advanced disease that could be treated by surgery

  4. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS)

  5. Patients with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS/AML.

  6. Patients receiving radiotherapy within 6 weeks prior to study treatment.

  7. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.

  8. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)

  9. Any previous treatment with PARP inhibitor, including olaparib.

  10. Clinically significant (e.g. active) cardiovascular disease, uncontrolled high blood pressure

  11. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub- Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.

  12. History or evidence of hemorrhagic disorders within 6 months prior to randomization

  13. Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome

  14. Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.

  15. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.

  16. Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) > grade 2) caused by previous cancer therapy, excluding alopecia.

  17. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.

  18. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.

  19. Pregnant or lactating woman

  20. Participation in another clinical study with an investigational product during he chemotherapy course immediately prior to randomization.

  21. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.

  22. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).

  23. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.

  24. Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids

  25. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr NC / NC Oui 01/10/2019
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Acronyme : ASPIK Prodige 50 - Prodige-50
Spécialité : Digestif
Traitement : Entretien
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

1/ screening des patients opérés d’un adénocarcinome du côlon stade III ou II à haut risque (cf infra) ET non consommateur d’aspirine en préopératoire (critères cf infra) :
consentement pour l’étude moléculaire de la tumeur colique

2/ Après signature d’un consentement spécifique : Recherche d’une mutation de PI3K sur exon 9 ou 20 dans l’une des 28 plateformes labellisées.

3/ Pour les patients présentant la mutation PI3K, proposition d’inclusion dans l’étude thérapeutique (consentement) une randomisation sera réalisée selon un ratio 1/1 :, aspirine 100 mg/j (1 comprimé) versus placebo (1 comprimé) par jour pendant 3 ans. Le traitement doit débuter dans les 60 jours post-opératoires

Informations

Adénocarcinome du colon stade III ou stade II

à fort risque de récidive - Mutation PIK3 (laboratoire centralisé)

Maintenance

Phase: 3

Promoteur: Fédération Francophone de Cancérologie Digestive (FFCD)
Autre(s) acronyme(s): Prodige 50 - Prodige-50
Contact promoteur: , France
Jérémie BEZ

Tel promoteur: tel : + 33 (0)3 80 39 34 83
fax : + 33 (0)3 80 38 18 41
Coordonnateur: Pr. P. Michel, CHU Rouen

Mail coordonnateur: ( pierre.michel@chu-rouen.fr )
-
Source: FFCD Site 19/12/2016
http://www.ffcd.fr/index.php/essais-therapeutiques/colon/36-essais-therapeutiques/colon/369-prodige-50-aspik

Cet essai dans d'autres annuaires :

Titre :

Etude prospective randomisée en double aveugle aspirine versus placebo chez les patients opérés d’un adénocarcinome du colon stade III ou II à haut risque de récidive avec mutation PI3K. Etude française ASPIK. PRODIGE 50.

Critères d'inclusion :
  1. Age > 18 ans

  2. Adénocarcinome du côlon de stade III

  3. Adénocarcinome Stade II à haut risque MSS

  4. T4bN0 or T4aN0 tumeur pénétrant la surface du péritoine viscéral

  5. ou moins de 12 ganglions examinés

  6. ou au moins deux des critères suivants : envahissement lymphatique, invasion périnerveuse, invasion veineuse ; ou diagnostic sur syndrome occlusif ou sur une perforation ; ou tumeur peu différenciée).

  7. mutation PI3K, exon 9 ou 20 (tumeur)

  8. Résection R0

  9. OMS 0-2

  10. Tomodensitométrie thoracique et abdominale datant de moins de 8 semaines.

  11. Espérance de vie > 3 an

  12. Consentement écrit signé

Critères de non-inclusion :
  1. Traitement anticoagulants et/ou anti agrégants

  2. Consommation d’aspirine régulière (plus de 3 prises par semaine pendant au moins 3 mois pendant la dernière année)

  3. Contre-indication à l’aspirine : Allergie à l ‘aspirine, Antécédent d’ulcère gastroduodénal

  4. Insuffisance hépatique ou rénale sévère

  5. Femme enceinte ou allaitante

  6. Cancer du rectum

  7. Forme héréditaire (i.e. syndrome de Lynch)

  8. Suivi impossible

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Quimper - CHI Cornouaille Dr BIDEAU - Pascaline Rameau - p.rameau@ch-cornouaille.fr 1 / NC Oui 03/01/2019
Saint Malo - Clinique de la Côte d'Émeraude Dr Raoul - - 1 / nc Oui 07/02/2019
Morlaix - Centre Hospitalier des Pays de Morlaix Dr Ferec - mferec@ch-morlaix.fr - 0 / nc Oui 03/01/2019
Plérin - CARIO - HPCA Dr Pierre-Luc ETIENNE - - / À venir 23/02/2018
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Pr Astrid Lièvre - UIC - 1 / 7 Oui 25/02/2019
Saint Malo - Centre Hospitalier de Saint Malo Dr Desgrippes - Stéphane Natur - Stephane.natur@ch-stmalo.fr 9 / 10 Oui 20/01/2020
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