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79 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : "BGB-290-303 2017-003493-13"
Spécialité : Digestif
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

"Experimental: Arm A
Approximately 270 subjects to receive BGB-290 orally.
Intervention: Drug: BGB-290

Placebo Comparator: Arm B
Approximately 270 subjects to receive placebo orally.
Intervention: Drug: Placebo"

Informations

Cancer de l'estomac locallement avancé inopérable ou métastatique

Ayant répondu à une première ligne de platine

maintenance

Phase: 3

Promoteur: BeiGene
Acronymes: BGB-290-303
2017-003493-13
Contact promoteur: Heinrich Farin, MD

Mail promoteur: Clinicaltrials@beigene.com
Tel promoteur: 781-801-1800
Coordonnateur: NR
-
Source: Clinicaltrials.gov du 02/05/2018"

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

Critères d'inclusion :
  1. "Age ≥ 18 years.

  2. Signed informed consent.

  3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.

  4. Received platinum based first line chemotherapy for ≤ 28 weeks.

  5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).

  6. Able to be randomized to study ≤ 8 weeks after last platinum dose.

  7. ECOG performance status ≤ 1.

  8. Adequate hematologic, renal and hepatic function.

  9. Must be able to provide archival tumor tissue for central biomarker assessment.

  10. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last "

Critères de non-inclusion :
  1. "Unresolved acute effects of prior therapy ≥ Grade 2.

  2. Prior treatment with PARP inhibitor.

  3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.

  4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.

  5. Diagnosis of myelodysplastic syndrome (MDS) or active bleeding disorder.

  6. Other diagnoses of significant malignancy

  7. Leptomeningeal disease or brain metastasis

  8. Inability to swallow capsules or disease affecting gastrointestinal function.

  9. Active infections requiring systemic treatment.

  10. Clinically significant cardiovascular disease

  11. Pregnant or nursing females."

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 J. P. Metges - RASSOUL HAYAT AGATHE - hayat.guezi@chu-brest.fr / Oui 02/05/2018
Rennes - Centre Eugène Marquis Dr Le Sourd Samuel - Enora Lejeune - nc / nc Oui 17/09/2018
Afficher les détails
Acronyme : "COMBIAPLUS-mélanome COMBI-Aplus CDRB436F2410"
Spécialité : Dermatologie
Traitement : Chimiothérapie adjuvante
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Dabrafenib and trametinib combination therapy
Subjects will receive dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.

Informations

Mélanome de stade III - Mutation BRAFV600- Adjuvant

Soins de support

Phase: 3 b

Promoteur: Novartis
Autre(s) acronyme(s): COMBIAPLUS-mélanome COMBI-Aplus
Contact promoteur: Novartis Pharmaceuticals
Mail promoteur: novartis.email@novartis.com


Tel promoteur: 41613241111
81337978748
Coordonnateur: NR
-
Source: Clinical trials 2018

Cet essai dans d'autres annuaires :

Titre :

Open label, phase IIIB study of Dabrafenib in combination with trametinib in the adjuvant treatment of stage III V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adaptated pyrexia AE-management algorythm.

Critères d'inclusion :
  1. Completely resected (R0) histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)]

  2. V600E/K mutation positive using a validated local test

  3. Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.

  4. Subjects with an unknown primary melanoma are not eligible.

  5. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).

  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Critères de non-inclusion :
  1. Uveal or mucosal melanoma

  2. Evidence of metastatic disease including unresectable in-transit metastasis

  3. Received any prior adjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma

  4. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ

  5. History or current evidence of cardiovascular risk

  6. A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy

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 Jacobzone - Nolwen Leissen - n.leissen@ch-bretagne-sud.fr

Tel: 02.97.06.74.61

NC / NC Oui 12/02/2019
Rennes - Centre Eugène Marquis Dr Thierry Lesimple - Sophie Gimenez - s.gimenez@rennes.unicancer.fr nc / nc Oui 12/02/2019
Afficher les détails
Acronyme : "CONTESSA ODO-TE-B301 CONTESSA-SEIN"
Spécialité : 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: Tesetaxel and Capecitabine
Tesetaxel (27 mg/m2) orally once every 21 days on Day 1 of each 21-day cycle; and Capecitabine (825 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle


Active Comparator: Arm B: Capecitabine
Capecitabine (1,250 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle

Informations

Cancer du SEIN

Métastasique - Avancé

3ieme ligne et plus

Doit avoir recu

  • Taxane (adjuvant, néoadjuvant)
  • Anthracyclines (néoadjuvant, adjuvant ou métastatique)
  • Hormonothérapie

Ne doit pas avoir recu

  • Pas plus de 1 ligne de chimiothérapie
  • Capécitabine
  • Taxane en métastatique

Phase 3

Promoteur: Odonate Therapeutics, LLC
Acronymes: CONTESSA ODO-TE-B301
CONTESSA-SEIN
Contact promoteur:
Contact: Valerie Legagneur
Contact: Jill Krause

Cet essai dans d'autres annuaires :

Titre :

Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane

Critères d'inclusion :

Amendement N°3 04/10/2018: critère d'inclusion N°5 modifié : ont été retirés :

Patient may have CNS métastases that are stable or progressing radiologically
Patient with current evidence of leptomeningeal disease are not eligible

 

  1. Female or male patients at least 18 years of age
  2. Histologically or cytologically confirmed breast cancer

  3. HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status.

  4. HR (ER and/or PgR) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status.

  5. Measurable disease per RECIST 1.1 or bone-only disease with lytic component. Patients with bone-only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a lytic component (ie, blastic-only metastasis) are not eligible.

  6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

  7. Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting

  8. Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.

  9. Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.

  10. Documented disease recurrence or disease progression of: (a) locally advanced disease that is not considered curable by surgery and/or radiation; or (b) metastatic disease.

  11. Adequate hematologic, hepatic, and renal function, as evidenced by:

    Absolute neutrophil count (ANC) ≥ 1,500/μL without colony-stimulating factor support

    Platelet count ≥ 100,000/μL

    Hemoglobin ≥ 10 g/dL without need for hematopoietic growth factor or transfusion support

    Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome

    Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN

    Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN

    Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULN

    Calculated creatinine clearance ≥ 50 mL/min

    Serum albumin ≥ 3.0 g/dL

    Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN; unless the patient is on a therapeutic anticoagulant

  12. Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy

  13. Ability to swallow an oral solid-dosage form of medication

  14. A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization)

  15. Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of Study treatment

    • Acceptable methods include: copper intrauterine device or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm

  16. Male patients must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 130 days after last dose of Study treatment

    • Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success.

  17. Written informed consent and authorization to use and disclose health information

  18. Ability to comprehend and comply with the requirements of the Stud

Critères de non-inclusion :

Amendement N°3 04/10/2018
Modification du critère d'exclusion N°4 : is revised to only exclude patients with know leptomeningeal desease
Modification du critère d'exclusio N°11 : is revised to allow for treatment with stereotactic brain radiosurgery within <14 days prior to the date of randomisation.

  1. Two or more prior chemotherapy regimens for advanced disease
  2. Prior treatment with a taxane in the metastatic setting

  3. Prior treatment with capecitabine

  4. Known metastases to the central nervous system

  5. Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the Study

  6. Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.

  7. Active hepatitis B or active hepatitis C infection

  8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study.

  9. Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0

  10. History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this Study

  11. Anticancer treatment, including endocrine therapy, radiotherapy, chemotherapy, biologic therapy, or therapy in an investigational clinical study, ≤ 14 days prior to the date of Randomization

  12. Major surgery ≤ 28 days prior to the date of Randomization; patient must have complete recovery from surgery

  13. Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the cytochrome P450 (CYP)3A or CYP2C9 pathways (patients should discontinue taking any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A or CYP2C9 pathways)

  14. History of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents, or any of their ingredients

  15. Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.

  16. Pregnant or breastfeeding

  17. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the Study

  18. Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of Randomization

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 Véronique DIERAS - v.dieras@rennes.unicancer.fr Perrette Quéric - p.queric@rennes.unicancer.fr / Oui 24/08/2018
Afficher les détails
Acronyme : "DUTRENEO MEDI4736 NEMIO-Vessie"
Spécialité : Urologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

"Active Comparator: Cisplatin-based neoadjuvant chemotherapy
Patients allocated to the control arm will receive any of the following cisplatin based neoadjuvant treatment:
Regimen 1: Gemcitabine + Cisplatin Regimen 2: Methotrexate + Vinblastine + Doxorubicin + Cisplatin Regimen 3: Gemcitabine + Paclitaxel + Cisplatin
Intervention: Drug: Cisplatin-based neoadjuvant chemotherapy

Experimental: Durvalumab plus Tremelimumab
Patients randomized to experimental arma will receive 28-day treatment cycle x 3 cycles of Durvalumab + Tremelimumab 75 mg every 4 weeks
Interventions:
Drug: Durvalumab
Drug: Tremelimuma"

Informations

Cancer de l'urothélium:  vessie,  uretère, urètre, pelvis rénal

Néoadjuvant

Phase: 2

Promoteur: Fundacion CRIS de Investigación para Vencer el Cáncer
Autre(s) acronyme(s): DUTRENEO MEDI4736
NEMIO-Vessie
Contact promoteur: Ana Moreno

Mail promoteur: ana.moreno@apices.es
Tel promoteur: 34918166804
Coordonnateur: NR
-
Source: Clinical trials.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Prospective Study to Individualize the Approach With DUrvalumab (MEDI4736) and TREmelimumab in NEOadjuvant Bladder Cancer Patients.

Critères d'inclusion :
  1. "Male and female subjects; age ≥ 18 years at the time of study entry.

  2. Subjects must provide written informed consent prior to performance of any protocol-related procedures, including screening evaluations and must be willing to comply with treatment and follow up.

  3. Subjects must have histologic documentation of transitional cell carcinoma of the urothelium (including the urinary bladder, ureter, urethra and renal pelvis) of the urinary tract (cystoscopy and biopsy or positive cytology).

  4. Patients must have confirmed cT2-T4 N0-1 M0 (TNM classification).

  5. Archival tumour samples for biomarker research in formalin-fixed and paraffin-embedded blocks.

  6. Body weight >30kg

  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  8. Life expectancy of at least 12 weeks

  9. Adequate organ function as determined by:

    a) Hematological (without growth factor or transfusion support within 28 days prior to first dose of investigational product)

    Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L).

    Platelets ≥ 100,000/mm3 (≥ 100 GI/L)

    Hemoglobin ≥ 9 g/dL (≥ 90 g/L)

  10. Hepatic:

    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN.

    Total bilirubin ≤ 1.5 × the upper limit of normal. For subjects with Gilbert's disease ≤ 3 mg/dL (≤ 51.3 μmol/L).

  11. Renal:

    a) Calculated CrCl or 24-hour urine CrCl>40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance

  12. Fasting serum triglycerides ≤ 2.5 × upper limit of normal AND total cholesterol ≤ 300 mg/dL (≤ 7.75 mmol/L). Lipid-lowering medication is allowed.

  13. HbA1c ≤ 8%.

  14. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause."

Critères de non-inclusion :
  1. "Histology of pure adenocarcinoma, pure squamous cell carcinoma, or predominant small cell carcinoma or sarcomatoid features in the tumor sample.

  2. Evidence of any metastatic lesion outside the primary tumour site identified in the radiological evaluation.

  3. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:

    Intranasal, inhaled, topical steroids or local steroid injections (eg, intra-articular injection).

    Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent.

    Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).

  4. Previous therapy with PD-1, PD-L1 or CTLA-4 inhibitors, including durvalumab and tremelimumab.

  5. Any concurrent chemotherapy, immunotherapy (IMT), or biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.

  6. History of severe allergic reactions (ie, Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of institution of supportive care) to any unknown allergens or any components of the study drug formulations.

  7. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:

    Patients with vitiligo or alopecia

    Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement

    Any chronic skin condition that does not require systemic therapy

    Patients without active disease in the last 5 years may be included but only after consultation with the study physician

    Patients with celiac disease controlled by diet alone

  8. Major surgery within 4 weeks of study randomization.

  9. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.

  10. Prior radiation therapy to >25% of the bone marrow.

  11. Current treatment on another clinical trial.

  12. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.

  13. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.

  14. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms (ECGs).

  15. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

    Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.

    Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.

  16. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)

  17. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).

  18. History of active primary immunodeficiency

  19. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive hepatitis B virus (HBV) surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV Ribonucleic acid (RNA).

  20. Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or C or active hepatitis A.

  21. Receipt of live, attenuated vaccine within 30 days prior to the first dose of investigational products.

  22. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.

  23. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

  24. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent

  25. History of leptomeningeal carcinomatosis"

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 Brigitte Laguerre - VALAT Sarah - NC / NC Oui 11/12/2018
Afficher les détails
Acronyme : "IMpassion132 MO39193 2016-005119-42"
Spécialité : Sénologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

" Experimental: Atezolizumab (gemcitabine, capecitabine, carboplatin)
Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle

Placebo Comparator: Placebo
Participants will receive Placebo on day 1 of each 3-week treatment cycle (gemcitabine, capecitabine, carboplatine)
"

Informations

Cancer du sein triple négatif

Locallement avancé, métastatique ou récidive

ayant recu anthracyclines et taxanes

Phase: 3

Promoteur: Hoffmann-La Roche
Acronymes: IMpassion132 MO39193
2016-005119-42
Contact promoteur: Study Director:
Reference Study ID Number: MO39193
Mail promoteur: global-roche-genentech-trials@gene.com
Tel promoteur: 888-662-6728 (U.S. and Canada)
Coordonnateur: NR
-
Source: clinicaltrials.org
24/08/2018"

Cet essai dans d'autres annuaires :

Titre :

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer

Critères d'inclusion :
  1. "Inclusion Criteria:

  2. Histologically confirmed triple negative breast cancer(TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic

  3. Documented disease progression occurring within 12 months from the last treatment with curative intent

  4. Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted

  5. Measurable or non-measurable disease, as defined by RECIST 1.1

  6. Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumour block (preferred) or at least 25 unstained slides with an associated pathology report, if available

  7. Eastern Cooperative Oncology Group performance status 0-1

  8. Life expectancy ≥ 12 weeks

  9. Adequate haematologic and end-organ function

  10. Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening

  11. Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening

  12. The HBV DNA test will be performed only for patients who have a positive HBcAb test

  13. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.

  14. Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤1% per year during the treatment period and for at least 5 months after the last dose of study treatment

  15. Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm"

Critères de non-inclusion :
  1. "Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation

  2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

  3. Symptomatic or rapid visceral progression

  4. No prior treatment with an anthracycline and taxane

  5. History of leptomeningeal disease

  6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed)

  7. Uncontrolled tumour-related pain

  8. Uncontrolled or symptomatic hypercalcemia

  9. Malignancies other than TNBC within 5 years prior to randomisation)

  10. Significant cardiovascular disease, within 3 months prior to randomisation, unstable arrhythmias, or unstable angina

  11. Presence of an abnormal ECG

  12. Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.

  13. Current treatment with anti-viral therapy for HBV.

  14. Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis

  15. Treatment with investigational therapy within 28 days prior to randomisation

  16. Pregnant or lactating, or intending to become pregnant during or within 5 months after the last 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 Véronique DIERAS - v.dieras@rennes.unicancer.fr Lucile MORVAN - / Oui 27/08/2018
Afficher les détails
Acronyme : "KEYNOTE716-mélanome 3475-716 2018-000669-35 MK-3475-716 KEYNOTE-716 KEYNOTE 716"
Spécialité : Dermatologie
Traitement : Thérapie ciblée adjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Pembrolizumab
Pediatric participants receive up to 17 cycles of 2 mg/kg (200 mg maximum) pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) in a double-blind design in Part 1. Adult participants receive up to 17 cycles of 200 mg pembrolizumab by IV infusion Q3W in a double-blind design in Part 1. Participants that complete 17 cycles of pembrolizumab and experience disease recurrence may be eligible to receive additional cycles of pembrolizumab in Part 2 in an open-label design. In Part 2, participants will receive up to 17 cycles of pembrolizumab for local/distant recurrence following resection of disease or up to 35 cycles of pembrolizumab for disease that cannot be resected or metastatic disease.


Placebo Comparator: Placebo
Participants receive up to 17 cycles of saline placebo by IV infusion Q3W in a double-blind design in Part 1. Participants that complete 17 cycles of placebo and experience disease recurrence may be eligible to receive pembrolizumab in Part 2 in an open-label design. In Part 2, participants will receive up to 17 cycles of pembrolizumab for local/distant recurrence following resection of disease or up to 35 cycles of pembrolizumab for disease that cannot be resected or metastatic disease.

Informations

Mélanome stade IIB, IIC

Immunothérapie adjuvante

Phase : 3

Promoteur: Merck Sharp & Dohme Corp
Autre(s) acronyme(s): KEYNOTE716-mélanome MK-3475-716/KEYNOTE-716
Contact promoteur: Merck Sharp & Dohme Corp
Mail promoteur: Trialsites@merck.com
Tel promoteur: 1-888-577-8839
Coordonnateur: NR
-
Source: Clinical trials 2018

Cet essai dans d'autres annuaires :

Titre :

Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study

Critères d'inclusion :
  1. Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines

  2. Has not been previously treated for melanoma beyond complete surgical resection of the current primary melanoma lesion

  3. Has ≤12 weeks between surgical resection and first study treatment

  4. Has no evidence of metastatic disease on imaging as determined by investigator

  5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale ≥50 for children up to and including 16 years of age at the time of enrollment

  6. Has recovered adequately from toxicity and/or complications from surgery prior to study start

  7. Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period

  8. Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are a woman of childbearing potential (WOCBP)

Critères de non-inclusion :
  1. Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines

  2. Has not been previously treated for melanoma beyond complete surgical resection of the current primary melanoma lesion

  3. Has ≤12 weeks between surgical resection and first study treatment

  4. Has no evidence of metastatic disease on imaging as determined by investigator

  5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale ≥50 for children up to and including 16 years of age at the time of enrollment

  6. Has recovered adequately from toxicity and/or complications from surgery prior to study start

  7. Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period

  8. Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are a woman of childbearing potential (WOCBP)

  9. Exclusion:

  10. Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) or surgery treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-ulcerated primary melanoma <1 mm in depth with no nodal involvement, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy

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

  12. Has recovered adequately from major surgery or the toxicity and/or complications from the intervention prior to starting study treatment

  13. WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

  14. Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (PD-L1) or anti-Programmed Cell Death Receptor Ligand 2 ( PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)

  15. Has received prior systemic anti-cancer therapy for melanoma including investigational agents

  16. Has received a live vaccine within 30 days prior to the first dose of study treatment

  17. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

  18. Has severe hypersensitivity (≥Grade 3) to any excipients of pembrolizumab

  19. Has an active autoimmune disease that has required systemic treatment in the past 2 years

  20. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

  21. Has an active infection requiring systemic therapy

  22. Has a known history of human immunodeficiency virus (HIV) infection

  23. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus (defined as Hepatitis C virus ribonucleic acid ((RNA)) [qualitative] is detected) infection

  24. Has a history of active tuberculosis (Bacillus tuberculosis)

  25. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

  26. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

  27. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study starting with the screening visit through 120 days after the last dose of study treatment

  28. Has had an allogeneic tissue/solid organ transplan

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 Thierry Lesimple - - nc / nc Oui 07/01/2019
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Acronyme : "PRAKYFRA-01-T.Solides PRAKYFRA-01 2018-002293-44"
Spécialité : Autres
Traitement : Palliatif / Soins de support
Ouvert aux inclusions : Oui

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Phase(s) : Sans phase
Descriptif

Randomisation : AKYNZEO versus traitement de référence incluant l'EMEND

Informations

Cancer tumeur maligne solide

Soins de support 

Phase: sans
Promoteur: VIFOR France
Autre(s) acronyme(s): PRAKYFRA-01-T.Solides PRAKYFRA-01
2018-002293-44
Contact promoteur: CAPIONIS
Mail promoteur: stephane.ouary@capionis.com
Tel promoteur: 33662755802
Coordonnateur: NR
-
Source: EU Clinical Trial Register

Cet essai dans d'autres annuaires :

Titre :

A Pragmatic randomized study to evaluate the comparative effectiveness of Akynzeo® and Standard of care (including Emend®) for the prevention of nausea and vomiting (CINV) in cancer patients receiving moderately emetogenic chemotherapy in France

Critères d'inclusion :
  1. Informed consent of the patient 

  2. Male or female, Age ≥ 18 years

  3. Have a histological or cytological confirmed solid tumor malignancy 

  4. Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor 

  5. Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator’s

  6. Naïve of CT

  7. ECOG performance up to 2

  8. Able to read, understand and follow the study procedures

Critères de non-inclusion :
  1. Pregnancy;

  2. Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;

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 Claire LARIBLE - Enora Michel - e.michel@rennes.unicancer.fr NC / NC Oui 08/01/2019
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Acronyme : "THOR-Vessie CR108401 2017-002932-18 THOR 42756493BLC3001"
Spécialité : Urologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

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Phase(s) : Phase III
Descriptif

"Experimental: Cohort 1 (Arm 1A): Erdafitinib
Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).

Experimental: Cohort 1 (Arm 1B): Vinflunine or Docetaxel
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.

Experimental: Cohort 2 (Arm 2A): Erdafitinib
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).

Experimental: Cohort 2 (Arm 2B): Pembrolizumab
Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.

Informations

Carcinomes à cellules transitionnelles de l'urothélium progressifs

 (Des composants mineurs (moins de < 50% [%] au total) de variantes histologiques telles que la différenciation glandulaire ou squameuse, ou l'évolution vers des phénotypes plus agressifs tels que le changement sarcomatoïde ou micropapillaire sont acceptables)

Appareil urinaire

2ième ligne métastatique

Phase: 3

Promoteur: Janssen Research & Development, LLC
Acronymes: THOR-Vessie CR108401
2017-002932-18 THOR
42756493BLC3001
Contact promoteur: Study Contact

Mail promoteur: JNJ.CT@sylogent.com
Tel promoteur: 844-434-4210
Coordonnateur: Janssen Research & Development, LLC Clinical Trials Janssen Research & Development, LLC

-
Source: Clinical trials.gov le 02/08/2019"

Cet essai dans d'autres annuaires :

Titre :

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Critères d'inclusion :
  1. "Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than < 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable

  2. Metastatic or surgically unresectable urothelial cancer

  3. Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization

  4. Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)

  5. A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)

  6. Participants must meet appropriate molecular eligibility criteria

  7. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

  8. Adequate bone marrow, liver, and renal function"

Critères de non-inclusion :
  1. "Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization

  2. Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 12 months prior to full study screening and considered completely cured

  3. Symptomatic central nervous system metastases

  4. Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment

  5. Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients

  6. Corneal or retinal abnormality likely to increase the risk of eye toxicity or lens conditions, such as untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test

  7. History of uncontrolled cardiovascular disease

  8. Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions"

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 Brigitte Laguerre - - / Oui 12/11/2018
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Acronyme : "TRITON2 CO-338-052 "
Spécialité : Urologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

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Phase(s) : Phase II
Descriptif

Experimental: Rucaparib

Oral rucaparib (monotherapy)

Informations
Cancer de la prostate / Adenocarcinome ou carcinome peu différencié 
 
2ieme ligne métastatique après une 1ère ligne de chimiothérapie à base de Taxane"
 
Progression après castration hormonale ou chirurgicale

(BRCA1/2+ ou ATM +)
 
Amendement le 05/1/2018
La cohorte B (non mesurable) est suspendue aux inclusions
 
Amendement le 02/08/2018
Le critère d'inclusion 5 a été scindé en 2 critères pour mieux distinguer l'exigence d'une progressionde la maladie des exigences relatives aux traitements antérieurs. Ceux-ci sont devenus les critères 5 et 6 et la numérotation des critères d'inclusion  été ajustée.[
 
"Phase: 2

Promoteur: Clovis Oncology, Inc.
Acronymes: TRITON2
CO-338-052 
Contact promoteur: Clovis Oncology Clinical Trial Navigation Service

Mail promoteur: clovistrials@emergingmed.com
Tel promoteur: 1-303-625-5160 (ex-USA)
Coordonnateur: NR
-
Source: https://clinicaltrials.gov/ct2/show/NCT02952534?term=triton+2&cond=Prostate+Cancer&rank=1"

Cet essai dans d'autres annuaires :

Titre :

A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

Critères d'inclusion :
  1. Be 18 years old at the time the informed consent form is signed

  2. Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate

  3. Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)

  4. Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease

  5. Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

 

Critères de non-inclusion :
  1. Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer

  2. Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy

  3. Symptomatic and/or untreated central nervous system metastases

  4. Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib

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 Brigitte Laguerre - Enora Lejeune - / Oui 29/01/2018
Plérin - CARIO - HPCA Dr Anne-Claire HARDY-BESSARD - Aude Vincent - a.vincent@bec22.fr / Oui 19/03/2018
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Acronyme : "VIOLETTE-Sein D5336C00001 VIOLETTE
Spécialité : Gynécologie - Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

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Phase(s) : Phase II
Descriptif

Active Comparator: Olaparib monotherapy
All randomized patients will receive Olaparib monotherapy 300 mg twice daily (BD).
Intervention: Drug: Olaparib Continuous (28-Day cycle) 300 mg BD.


Active Comparator: Olaparib+AZD6738
All randomized patients will receive Olaparib 300 mg twice daily+AZD6738 160 mg once daily (OD).
Intervention: Drug: AZD6738 160 mg OD + olaparib continuous 300 mg BD (28-day cycle).


Active Comparator: Olaparib+AZD1775
All randomized patients will receive Olaparib 200 mg BD +AZD1775 175 mg BD.
Intervention: Drug: AZD1775 175 mg BD + olaparib 200 mg BD (21-day cycle).

Informations

Cancer du sein triple négatif avancé métastatique

2ème ou 3ème ligne

Phase: 2


Promoteur: Astra Zénéca
Autre(s) acronyme(s): D5336C00001
Violette
Contact promoteur: AstraZeneca
Mail promoteur: information.center@astrazeneca.com
Tel promoteur: 877-240-9479
Coordonnateur: Andrew Tutt,

-
Source: Clinical trial novembre 2018

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE).

Critères d'inclusion :
  1. Provision of informed consent prior to any study specific procedures 

  2. Patients must be male or female ≥18 years of age. 

  3. Progressive cancer at the time of study entry with a life expectancy of ≥16 weeks 

  4. Histologically or cytologically confirmed TNBC with evidence of metastatic disease as per ASCO-CAP HER2 guideline recommendations 2013 

  5. Patients must have received at least 1 and no more than 2 prior lines of treatment for metastatic disease with an anthracycline (eg, doxorubicin, epirubicin) and/or a taxane (eg, paclitaxel, docetaxel) unless contraindicated, in either the neo-adjuvant, adjuvant or metastatic setting.

  6. Confirmed presence of qualifying HRR mutation or absence of any HRR mutation in tumour tissue by the Lynparza HRR assay.

  7. At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging [MRI] where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1.

  8. Patients must have normal organ and bone marrow function measured within 28 days prior to randomisation as defined by protocol ECOG PS 0-1 within 28 days of randomisation. 

  9. Patients must be willing to comply with the protocol requirements

 

Critères de non-inclusion :
  1. Cytotoxic chemotherapy, hormonal or non hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 21 or more days before Cycle 1 Day 1. The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 5 days prior to study treatment.

  2. More than 2 prior lines of cytotoxic chemotherapy for metastatic disease.

  3. Previous randomisation in the present study.

  4. Previous treatment with a PARP inhibitor (including olaparib) or other DDR inhibitor (unless treatment was for less than 3 weeks duration and at least 12 months have elapsed between the last dose and randomisation. Patients that did not tolerate prior treatment are excluded).

  5. Exposure to a small molecule IP within 30 days or 5 half-lives (whichever is longer) prior to randomisation.The minimum washout period for immunotherapy shall be 42 days.

  6. Patients with MDS/AML or with features suggestive of MDS/AML.

  7. Patients with second primary cancer, EXCEPTIONS: adequately treated non melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years prior to study entry.

  8. Mean resting corrected QTc interval using the Fridericia formula (QTcF) >470 msec/female patients and >450 msec for male patients or congenital long QT syndrome.

  9. Any of the protocol specified cardiac diseases currently or within the last 6 months defined by New York Heart Association (NYHA) ≥ Class 2:

  10. Concomitant use of known strong cytochrome P (CYP) 3A inhibitors or use of known strong or moderate CYP3A inducers.

  11. Persistent toxicities (≥ CTCAE grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE grade 2 peripheral neuropathy.

  12. Major surgery within 2 weeks of starting study treatment: patients must have recovered from any effects of any major surgery.

  13. Immunocompromised patients, eg,human immunodeficiency virus (HIV) patients.

  14. Patients with known active hepatitis (B or C).

  15. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease or active, uncontrolled infection.

  16. Patients with symptomatic uncontrolled brain metastases.

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

  18. Patients with a known hypersensitivity to olaparib, AZD1775, AZD6738, or any of the excipients of the products.

  19. Pregnant or breast feeding women."

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 - Véronique BRIEUC - v.brieuc@rennes.unicancer.fr nc / nc Oui 26/11/2018
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Fiche détaillée de l'essai