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367 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : " COMBO D5330C00004"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase Ia, Phase Ib
Descriptif

Experimental: Module 1 Part A
Module 1 Part A: ascending doses of AZD6738 in combination with carboplatin AUC5 will be administered to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 1 Part B
Module 1 Part B: patients with advanced lung adenocarcinoma with low expression of ATM will receive AZD6738 and carboplatin, at the dose, frequency and schedule recommended from Module 1 Part A.
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 2 Part A1
Module 2 Part A1: ascending doses of AZD6738 will be administered alone to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) to take into Module 2 Part A2.
Intervention: Drug: Administration of AZD6738

Experimental: Module 2 Part A2
Module 2 Part A2: ascending doses of AZD6738 will be administered in combination with olaparib to patients to define the dose, frequency and schedule of AZD6738 and olaparib to take into Module 2 Part B.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B1
Module 2 Part B1: Patients with second line 'ATM deficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B2
Module 2 part B2: Patients with second line 'ATM proficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B3
Module 2 Part B3: Patient with second or third line breast cancer with BRCA mutations (somatic or germline), excluding HER2 positive breast cancer will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B4
Module Part B4: Patients with second or third line triple negative breast cancer with no known BRCA mutations. This expansion will be enriched for patients with disease harbouring a HRR-related gene mutation (HRRm) will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 3 Part A
Module 3 Part A: cohort escalation of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients to define the dose, frequency and schedule of AZD6738 and MEDI4736 to take into Module 3 Part B.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Experimental: Module 3 Part B
Module 3 Part B: cohort expansions of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients at dose, frequency and schedule from Module 3 Part A.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Informations

ATM deficient, ATM proficient, HER2 negative, Breast, Gastric, Head & Neck, Lung

cancer métastatique

ligne de traitement variable selon les organes

 

12/12/2018
B3 : cancer du sein HER2 négatif avec mutation BRCA1 ou BRCA2 somatique ou germinale, en 2ème et 3ème ligne : Fermé
B4 : cancer du sein triple négatif sans mutation BRCA1 ou BRAC2 identifiée, en 2ème ou 3ème ligne : Ouvert

 

Phase: 1,1b,

Promoteur: AstraZeneca
Autre(s) acronyme(s): D5330C00004
Contact promoteur: AstraZeneca Clinical Study Information Center
AstraZeneca Cancer Study Locator Service

-
Source: Clinical trials.gov le 02/08/2018"

Cet essai dans d'autres annuaires :

Titre :

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies

Critères d'inclusion :
  1. "Aged at least 18

  2. The presence of a solid malignant tumour that is not considered appropriate for further standard treatment

  3. Module 1 and 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan

  4. Module 1 Part B Study expansion: second line lung adenocarcinoma with ATM deficient tumours.

  5. Module 2 Part B All - No previous treatment with PARP inhibitor.

  6. Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours

  7. Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours

  8. Module2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer

  9. Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC) Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma"

Critères de non-inclusion :
  1. "A diagnosis of ataxia telangiectasia

  2. Prior exposure to an ATR inhibitor

  3. Bad reaction to AZD6738

  4. Module 1: Contra-indicated for treatment with carboplatin

  5. Module 2: Contra-indicated for treatment with olaparib

  6. Module 3: Contra-indicated for treatment with MEDI4736"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest Dr CAMPONE Mario - - / Oui 11/09/2018
Afficher les détails
Acronyme : "2102-HEM-101 FT-2102 Forma FT-2102-HEM-101"
Spécialité : Hématologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

Experimental: PH1 Dose Escalation & Expansion FT-2102
Intervention: Drug: FT-2102


Experimental: PH1 Esc. and Exp. FT-2102+Azacitidine
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH1 Esc. and Exp. FT-2102+Cytarabine
Interventions:
Drug: FT-2102
Drug: Cytarabine


Experimental: PH2 Cohort 1 FT-2102 Single Agent
At the completion of Phase 1, Phase 2 Cohort 1 will commence enrollment wherein patients with relapsed or refractory (R/R) AML will be treated with the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 2 FT-2102 Single Agent
In Phase 2 Cohort 2, patients with AML/ MDS in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after cytotoxic-containing induction therapy with residual IDH-R132 mutation will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 3 FT-2102 Single Agent
In Phase 2 Cohort 3, patients with R/R AML/MDS, previously treated with an IDH1 inhibitor will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 4 FT-2102+Azacitidine
In Phase 2 Cohort 4, patients with R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 5 FT-2102+Azacitidine
In Phase 2 Cohort 5, patients with R/R AML/MDS that have inadequately responded or have progressed immediately proceeding hypomethylating therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 6 FT-2102+Azacitidine
In Phase 2 Cohort 6, patients with R/R AML/MDS that have been previously treated with single-agent IDH1 inhibitor therapy as their last therapy prior to study enrollment will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine

Informations

Leucémie myéloïde aiguë ou de syndrome myélodysplasique

mutation IDH1

récidivant ou réfractaire

2ème ligne ou +

Phase: 1,2

Promoteur: NR
Acronymes: 2102-HEM-101 FT-2102
Promoteur : Forma FT-2102-HEM-101

Source: Clinical trial.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

Critères d'inclusion :
  1. Pathologically proven acute myeloid leukemia (AML) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.

  2. Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site

  3. Good performance status

  4. Good kidney and liver function

Critères de non-inclusion :
  1. Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy

  2. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias

  3. Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication

  4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therap

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 Dr Nimubona - - 0 / 0 Oui 29/11/2018
Afficher les détails
Acronyme : "ARRAY-818-302  2015-005805-35 BEACON CRC
Spécialité : Digestif
Traitement : Récidive
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Safety Lead-in, Triplet Arm
Encorafenib + binimetinib + cetuximab.

Experimental: Doublet Arm
Encorafenib + cetuximab.

Active Comparator: Control Arm
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.
Interventions:
Drug: Cetuximab
Drug: Irinotecan
Drug: Folinic Acid
Drug: 5-Fluorouracil

Informations

Cancer Colorectal Métastatique

BRAF V600E-mutant

2ème ligne et +

Phase 3

Promoteur: Array BioPharma
Acronymes: 2015-005805-35
BEACON CRC
Contact promoteur:
Array BioPharma
Mail promoteur: clinicaltrials@arraybiopharma.com

Tel promoteur:
303-381-6604

-
Source: Clinical trial.gov du 25/06/2018"

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

Critères d'inclusion :
  1. Age ≥ 18 years at time of informed consent

  2. Histologically- or cytologically-confirmed CRC that is metastatic

  3. Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory

  4. Progression of disease after 1 or 2 prior regimens in the metastatic setting

  5. Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1

  6. Adequate bone marrow, cardiac, kidney and liver function

  7. Able to take oral medications

  8. Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of childbearing potential

  9. Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-u

Critères de non-inclusion :
  1. Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab, panitumumab or other EGFR inhibitors

  2. Prior irinotecan hypersensitivity or toxicity that would suggest an inability to tolerate irinotecan 180 mg/m2 every 2 weeks

  3. Symptomatic brain metastasis or leptomeningeal disease

  4. History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)

  5. Known history of acute or chronic pancreatitis

  6. History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization

  7. Uncontrolled blood pressure despite medical treatment

  8. Impaired GI function or disease that may significantly alter the absorption of encorafenib or binimetinib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)

  9. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy

  10. History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli

  11. Concurrent neuromuscular disorder that is associated with the potential of elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)

  12. Residual CTCAE ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy

  13. Known history of HIV infection

  14. Active hepatitis B or hepatitis C infection

  15. Known history of Gilbert's syndrome

  16. Known contraindication to receive cetuximab or irinotecan at the planned doses

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - CHU Hépato-Digestif Dr Touchefeu Yann - DZIUKALA Catherine - / À venir 12/07/2018
Brest - CHU de Brest - Site Morvan Dr J. P. Metges - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr NC / NC Oui 12/07/2018
Afficher les détails
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 : "Bladder-ART GETUG-AFU 30 UC-01610/1617"
Spécialité : Urologie
Traitement : Traitement adjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Sans phase
Descriptif

Experimental: Experimental Arm
adjuvant pelvic radiotherapy consisting of 28 x 1.8 Gy fractions (total dose of 50.4 Gy), 5 days per week, 1 fraction /day (duration of RT is 38 days).
Intervention: Radiation: pelvic radiotherapy


No Intervention: Standard Arm
Surveillance

Informations

Carcinome urothélial pur ou dominant supérieur ou égale à 50 % associé à des variants histologiques micropapillaire, épidermoïde ou adénocarcinome

Vessie

 

Radiothérapie adjuvante

Sans Phase

Promoteur: UNICANCER
Acronymes: Bladder-ART GETUG-AFU 30
UC-01610/1617
Contact promoteur: Sandra PELISSIER

Mail promoteur: s-pelissier@unicancer.fr
Tel promoteur: 33 1 44 23 55 68
Coordonnateur:
Paul SARGOS,
Stéphane LARRE, Prof
Mail coordonnateur: MD Institut Bergonié
CHU Robert Debré
-
Source: Clinical trial octobre 2018"

Cet essai dans d'autres annuaires :

Titre :

Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer: A Randomized Multicentre Phase II Study

Critères d'inclusion :

To be eligible, the patients must fulfil all of the following inclusion criteria:

  1. Patients with histologically-confirmed muscle-invasive bladder cancer, either with pure urothelial carcinomas, or dominant urothelial carcinomas (>50%) combined with other histological variants including: micropapillary, epidermoid, or adenocarcinomas, are eligible. Patients with small cell variants, pure adenocarcinomas, or pure epidermoid carcinomas are not eligible.

  2. Patients with radical cystectomy and pelvic lymph nodes dissection with no macroscopic residual disease (R0 and R1).

    Note that only R1 patients without urinary diversion as orthotropic neo-bladder replacement are eligible for the study, to limit cystectomy bed radiation induced toxicities

  3. Patients with tumours of TNM staging: pN0-2, M0 by imagery, and pT3a, pT3b, pT4a, and pT4b, as well as, pTX-pN1-2 are eligible.

  4. Patients having received neo-adjuvant or adjuvant chemotherapy treatment are eligible. Randomisation is allowed only if AE due to chemotherapy are ≤grade 2

  5. Patients ≥18 years old.

  6. ECOG performance status ≤2.

  7. Absolute neutrophil count (ANC) ≥1500 cells/mm3

  8. Platelets ≥100000 cells/mm3

  9. Haemoglobin ≥8 g/dL (Note: following a blood transfusion or another intervention if required).

  10. Adequate hepatic function: AST (SGOT) and ALT (SGPT) ≤2.5 x ULN; or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.

  11. Adequate renal function: clearance >30 mL/min (MDRD).

  12. Patients of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 6 months after the adjuvant radiotherapy. Acceptable method of contraception includes: hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal associated with inhibition of ovulation (oral, intravaginal, transdermal), intrauterine devices, sexual abstinence, bilateral tubal ligation, vasectomy, for female: partner who have had a vasectomy, for male: partner who is not of childbearing potential. Women must have a negative urine or serum pregnancy test within 14 days prior to randomization.

  13. Patients having provided written informed consent prior to any study-related procedures.

  14. Patients affiliated to the social security scheme.

  15. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

Critères de non-inclusion :

Patient must not be enrolled if he/she fulfils any of the following non-inclusion criteria:

  1. Patients with R1 resection and with orthotropic neo-bladder reconstruction as urinary diversion are not eligible.

  2. Patients with clinical or radiological evidence of metastases or N3 staged bladder cancer are not eligible.

  3. Prior invasive solid tumours or haematological malignancies (except skin basal cell carcinoma, in situ epithelioma of the cervix, or prostate cancer [incidentally discovered during cystoprostatetectomy and pelvic lymph node dissection)] and with a good prognosis [T stage <pT3b and/or Gleason <8 and pN- and/or post-operative PSA <0.1 nanogramm/mL]), unless disease free for a minimum of three years prior to inclusion.

  4. Prior pelvic radiotherapy.

  5. Patients with active inflammatory bowel disease.

  6. Patients who required surgical treatment for bowel obstruction before bladder cancer diagnosis or after cystectomy.

  7. Prior chemotherapy for other malignant diseases, except for neoadjuvant pre-cystectomy chemotherapy which is permitted.

  8. Patients with the following severe acute co-morbidity are not eligible:

    Unstable angina or congestive heart failure that required hospitalization in the 6 months before randomisation.

    Transmural myocardial infarction in the 6 months prior to randomisation.

    Acute bacterial or fungal infection requiring intravenous antibiotics at randomization.

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of inclusion.

    Severe hepatic disease: Child-Pugh Class B or C hepatic disease.

    Known acquired immune deficiency syndrome (AIDS); the study treatment could impact blood count.

  9. Patients with any other disease or illness which requires hospitalization or is incompatible with the study treatment are not eligible.

  10. Patients unable to comply with study obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the study.

  11. Patients enrolled in another therapeutic study within 30 days prior of randomisation.

  12. Pregnant or breast feeding mothers.

  13. 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
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Artignan - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com / Oui 26/11/2018
Afficher les détails
Acronyme : "CHEMOIMMUNE ET16-073 2016-002736-33 "
Spécialité : Sénologie
Traitement : Thérapie ciblée néoadjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

"Cyclophosphamide et pembrolizumab
The treatments received are:

  • cyclophosphamide (50 mg/day, daily, per os)
  • pembrolizumab (200 mg every 3 weeks, intravenously [IV]). On days 1, cyclophosphamide should be taken first and pembrolizumab infusion initiated within 1 hour after cyclophosphamide intake.

Interventions:
Drug: Cyclophosphamide 50mg
Drug: Pembrolizumab 100 MG in 4 ML Injection"

Informations

Cancer du sein métastatique - HER2- 

> ou = 2ieme ligne de traitement 

1iere ligne si prétraitée en néoadjuvant ou adjuvant par une thérapie à base de taxane ou anthracycline

Phase: 2

Promoteur: Centre Léon Berard
Autre(s) acronyme(s): ET16-073
2016-002736-33
Contact promoteur:
Contact: Olivier TREDAN, MD

Mail promoteur: olivier.tredan@lyon.unicancer.fr
Tel promoteur: 33478782828
-
Source: clinicaltrials.gov 18/06/2018"

Cet essai dans d'autres annuaires :

Titre :

CHEMOIMMUNE - A Phase II Study Evaluating an Anti-PD1 Monoclonal Antibody (Pembrolizumab) in Lymphopenic Metastatic Breast Cancer Patients Treated With Metronomic Cyclophosphamide

Critères d'inclusion :
  • Female patient>=18 years of age on day of signing informed consent.

  • Histologically proven HER2-negative metastatic breast cancer. HER2-negativity is defined as immunohistochemistry (IHC) score 0, 1+ or 2+ and fluorescent in situ hybridization (FISH) negative or just FISH negative, whichever was performed.

  • Patient previously treated with at least one prior line of standard chemotherapy either in the adjuvant setting or in the metastatic setting. Patients may be included in the first line metastatic setting if they have received anthracycline and/or taxane-based therapy in the neoadjuvant/adjuvant setting.

Note: Patients with ER-positive tumors must have received at least one prior endocrine therapy, either in the adjuvant setting or in the metastatic setting.
Documented lymphopenia defined by at least one value of lymphocyte count < 1.5 G/L within 15 days before treatment start (C1D1) and following at least 15 days since the last administration of chemotherapy.
Biopsiable disease i.e. at least one lesion with a diameter ≥ 10 mm, visible by medical imaging and accessible to percutaneous sampling.
Patient willing to undergo 2 tumor biopsies (at inclusion and at C3D1).
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 and minimum life expectancy of 24 weeks.

  • Documented radiological disease progression at time of study entry.

  • At least one measurable lesion according to RECIST 1.1.

  • Adequate end organ and marrow function as defined below: all screening labs should be performed within 3 days before treatment start (C1D1).

Hematological Laboratory Values Absolute neutrophil count (ANC) ≥ 1.5G/L Platelets ≥ 100G/L Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (without transfusion within 7 days of assessment) Renal Laboratory Values Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or Calculated creatinine clearance as per MDRD or CKD-EPI formula ≥ 60 mL/min /1.73m2 Hepatic Laboratory Values Serum total bilirubin ≤ 1.5 X ULN or Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN LDH ≤ 1.5 ULN Albumin ≥ 25 g/L Coagulation Laboratory Values International Normalized Ratio (INR) ≤ 1.5 ULN Ratio of activated Partial Thromboplastin Time (aPTT) ≤ 1.5 ULN

  • Absence of prior significant treatment-related toxicity i.e. treatment-related toxicity > Grade 1 as per CTCAE v4.03 (Appendix 2), except grade 2 alopecia, grade 2 neuropathy and biological values as described in I10.

  • Women of child-bearing potential must have a negative serum pregnancy test within 3 days before C1D1.

  • Women of child-bearing potential must agree to use 2 effective forms of contraception from the time of the negative pregnancy test up to 120 days after the last dose of study drugs. Effective forms are detailed in Appendix 5.

  • Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.

  • Patients must be covered by a medical insurance.

Critères de non-inclusion :
  • Previously treated with more than 3 prior lines of chemotherapy in the metastatic setting

  • Has previously received therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand 1(PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.

  • Presenting any contraindication to cyclophosphamide treatment including known hypersensitivity to cyclophosphamide, inflammation of the bladder (cystitis), urinary outflow obstruction or active infection.

  • Requiring the use of concomitant medications defined as forbidden in the SPC of cyclophosphamide.

  • Hypersensitivity to pembrolizumab or any of its excipients.

  • Has a known history of active Bacillus Tuberculosis.

Prior treatment with:

  1. any investigational agent within 4 weeks before C1D1 (or 5 half-lives whichever is shorter with a minimum of 2 weeks);
  2. any systemic corticosteroids at doses higher than 10 mg/d of prednisolone or equivalent or immunosuppressive agent within 4 weeks before C1D1;
  3. any monoclonal antibody within 4 weeks before C1D1;
  4. any chemotherapy, targeted small molecule therapy, radiation therapy, or surgery within 2 weeks prior to C1D1.

Note: If a patient underwent a major surgical procedure, they must have adequately recovered from the toxicity (i.e. wound healing) and/or complications from the intervention prior to starting therapy.
* any live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.

  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 28 days prior to C1D1. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.

  • Has active autoimmune disease that has required systemic treatment in the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d of methylprednisolone or equivalent or immunosuppressive agents.

Note: Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.

  • Has an history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active non-infectious pneumonitis.

  • Has an active infection requiring systemic therapy.

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

  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

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

  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest FRENEL Jean Sébbastien - - / Oui 19/06/2018
ANGERS - Institut de Cancérologie de l'Ouest Dr FRENEL Jean Sebastien - - / Oui 19/06/2018
Afficher les détails
Acronyme : "CLAG525X210C CPDR001XUS01 "
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: PDR001 and LAG525

PDR001 will be supplied as powder for solution for infusion. LAG525 will be supplied as a liquid formulation. PDR001 and LAG525 will be administered via i.v. infusion over 30 minutes once every 3 weeks. LAG525 will be given first followed by PDR001.
Biological: PDR001
PDR001 is a high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.

Biological: LAG525

Informations

Toutes tumeurs solides 

Récidives, rechute, métastatiques

2ieme ligne et plus

  • "Poumon petites cellules
  • ADK estomac
  • ADK Oesophage
  • ADK prostate résitant
  • Sarcome tissus mous
  • ADK Ovaire
  • Tumeur Neuroendocrine avancée, bien différenciées
  • Diffuse Large B Cell Lymphoma"

Phase: 2

Promoteur: Novartis Pharmaceuticals
Autre(s) acronyme(s): NR
Contact promoteur: Study director
Mail promoteur: Novartis.email@novartis.com

Tel promoteur: 1-888-669-6682
Coordonnateur: NR
-
Source: 01/08/2018 Clinical Trials.com"

Cet essai dans d'autres annuaires :

Titre :

This is a phase II, open-label, parallel-cohort study to determine the efficacy and safety of treatment with the combination of PDR001+LAG525 across multiple tumor types that are relapsed and/or refractory to available standard of care therapies. Patients will receive study treatment for a maximum of 2 years, All disease assessments will be performed locally by the investigator.

Critères d'inclusion :
  1. Patients eligible for inclusion in this study have to meet all of the following criteria:

  2. Patient must have had at least one prior line of therapy for their disease and must not be beyond 4th progression/relapse of disease (5 maximum prior lines).

  3. Patient has a pathology confirmed diagnosis of a solid tumor or lymphoma listed in the section "condition". Patients must have measurable disease as per appropriate guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised Response Criteria for Malignant Lymphoma - Cheson et al 2007).

  4. Expansion Cohorts only: Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Exceptions may be considered after discussion with the sponsor.

Critères de non-inclusion :
  1. "History of severe hypersensitivity reactions to other mAbs.

  2. Impaired cardiac function or clinically significant cardiac disease.

  3. Active, known or suspected autoimmune disease or a documented history of autoimmune disease within three years prior to screening with a few exceptions as per protocol.

  4. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.

  5. Patient with second primary malignancy within < 3 years of first dose of study treatment.

  6. Prior immunotherapy treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest WIAZZANE Nadia - - / Oui 27/08/2018
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 : "COPAN-ORL06 UC-0130/1507 2015-004340-19 COPAN"
Spécialité : ORL
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

"Drug: Copanlisib
Copanlisib will be given at Day 1, Day 8 and Day 15 (1 cycle = 28 days), administered intravenously over 60 minutes, in association with Cetuximab.
Other Name: BAY 80-6946

Drug: Cetuximab
Cetuximab will be given weekly at Day 1, Day 8, Day 15 and Day 22 (1 cycle = 28 days), administered intravenously over 120 minutes (Cycle 1 Day 1) or 60 minutes (subsequent infusions), in association with Copanlisib.
Other Name: Erbitux"

Informations

Carcinome épidermoïde de la tête et du cou

Recurrent ou métastatique

après platine / progression ou rechute après cétuximab

Mutation ou amplification PI3K and/or a PTEN loss

Phase: 1 b, 2

Promoteur: UNICANCER
Acronymes: COPAN-ORL06 UC-0130/1507
2015-004340-19
COPAN
Contact promoteur: Jessy DELAYE / Isabelle Jallut

Mail promoteur: j-delaye@unicancer.fr
Tel promoteur: +33 (0)1 44 23 04 11
+33 (0)1 44 23 55 77
-
Source: Clinicaltrials.gov du 21/06/2018"

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

Phase ib/II Trial of Copanlisib, a Selective PI3K Inhibitor, in Combination With Cetuximab in Patients With Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss.

Critères d'inclusion :
  1. "Patients with R/M HNSCC (oropharynx, oral cavity, hypopharynx and larynx), histologically or cytologically confirmed, not amenable to curative treatment with surgery and/or chemotherapy and/or radiotherapy (Stage III/IV)

  2. Adult men and women ≥ 18 years

  3. Patients with ECOG performance status 0 - 2 (ECOG: Eastern Cooperative Oncology Group)

  4. Patients with tumor harboring a PI3K mutation/amplification and/or a PTEN loss

  5. Patients with a radiologic documented progression or relapse after cetuximab therapy (patients could have either received combination platinum doublet with cetuximab or cetuximab after platinum doublet)

  6. Patients with prior platinum based therapy, unless contraindicated

  7. Patients with at least one measurable lesion assessed by Magnetic Resonance Imaging (MRI) or a computerized tomography scanner (CT-scan) according to RECIST 1.1. Patients must have clinically and/or radiographically documented measurable disease. At least one site of disease must be unidimensionally measurable as follows

  8. CT-scan, physical exam ≥ 10 mm

  9. Lymph node short axis ≥ 15 mm Tumor measurements must be performed within 28 days prior to starting study drug.

  10. Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies since signing of the informed consent form and up to 12 months (for women of child bearing potential) and 6 months (for fertile men) after the last study drug administration (Copanlisib). Highly effective contraception methods are detailed in section 7.2.

  11. Women of childbearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to starting study drug).

  12. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses

  13. Patients with social insurance coverage

  14. Glomerular filtration rate (GFR) ≥ 40 mL/min/1.73 m² according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula (within 7 days prior to starting study drug). If not on target, this evaluation may be repeated once after at least 24 hours either according to the MDRD abbreviated formula or by 24 hour sampling. If the later result is within acceptable range, it may be used to fulfill the inclusion criteria instead."

Critères de non-inclusion :
  1. "Patients previously treated with PI3K and/or mTOR inhibitors

  2. Patients with anticancer therapy (radiotherapy, immunotherapy, chemotherapy, etc.) within 28 days or investigational treatment within 28 days prior to the initiation of study drug treatment, unless evidence of progression since last treatment

  3. Patients currently using other approved or investigational anti-neoplasic agent

  4. Patients with uncontrolled arterial hypertension despite optimal medical management, Congestive heart failure > New York Heart Association (NYHA) class 2, Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of test drug No active cardiac disease including any of the following: left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) and QTc > 470 ms on screening ECG

  5. Patients with uncontrolled diabetes mellitus (patients with controlled Type I or II diabetes mellitus will be eligible but only into the phase II of the study and only if fasting HbA1c ≤ 8.5% at screening)

  6. Patients with a history of Human Immunodeficiency Virus (HIV) Hepatitis B (HBV) or hepatitis C (HCV) infection. All patients must be screened for HIV, HBV and HCV up to 28 days prior to first dosing using the routine virus laboratorial panel. Patients who are positive for HBs Ag or HBc Ab will be eligible if they are negative for HBV-DNA. Patients who are positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA

  7. Patients with active uncontrolled or symptomatic central nervous system (CNS) metastases. Patients are eligible if their disease is controlled at least 30 days on corticosteroids prior to starting study drug.

  8. Patients with major surgery within 28 days, or open biopsy within 7 days, prior to starting study drug. Patients must have recovered from major side effects of the surgery.

  9. Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible. Copanlisib is primarily metabolized by CYP3A4. Therefore concomitant use of strong inhibitors of CyP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir), and inducers of CYP3A (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, st. John's Wort) are not permitted from Day -14 of Cycle 1 until the Safety follow up visit.

  10. Patients with altered hematopoietic or organ function, as indicated by the following criteria (assessed within -7 days prior the first dosing):

  11. Absolute granulocytes < 1.0 ×109/L

  12. Platelets < 75 x 109/L

  13. ALAT/ASAT > 2.5 x ULN in the absence of or > 5x ULN in the presence of liver metastases

  14. Bilirubin > 1.5 x ULN (except Gilbert Syndrome : < 3.0 mg/dL)

  15. Creatinine clearance < 60 mL/min (measured or calculated by Cockcroft and Gault formula) or serum creatinine > 1.0 x ULN

  16. Lipase > 1.5 x ULN

  17. INR and PTT > 1.5 x ULN

  18. Patients with a history of hypersensitivity to other monoclonal antibodies or to the active or inactive excipients of study drug

  19. Known drug or alcohol abuse

  20. Known or underlying medical condition that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events

  21. History of uncontrolled seizures, seizure disorder requiring medication, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake

  22. Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study

  23. Individuals deprived of liberty or placed under the authority of a tutor

  24. Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated:

  25. Cervical carcinoma in situ

  26. Non-melanoma skin cancer

  27. Superficial bladder cancer (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria])

  28. Localized prostate cancer

  29. Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication

  30. Proteinuria of ≥ CTCAE Grade 3 as assessed by a 24h protein quantification or estimated by urine protein-creatinine ratio > 3.5 on a random urine sample

  31. History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)

  32. Concurrent diagnosis of pheochromocytoma

  33. Pregnant or breast-feeding patients. Women of childbearing potential must have a serum pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.

  34. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy/procedure, excluding alopecia

  35. Ongoing immunosuppressive therapy

  36. Blood or platelets transfusion less than 7 days before starting treatment

  37. Myeloid growth factors within 14 days prior to treatment

  38. Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent is not allowed. Previous corticosteroid therapy must be stopped or reduced to the allowed dose 7 days before performing the screening CT scan/MRI, whichever is performed first, and again prior to the first study drug administration. If a patient is on chronic corticosteroid therapy, corticosteroids should be de-escalated to the maximum allowed dose after the patient has signed the IC. Patients may be using topical or inhaled corticosteroids.

  39. History of having received an allogeneic bone marrow or organ transplant

  40. Anti-arrhythmic therapy (beta blockers or digoxin are permitted)"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
ANGERS - Institut de Cancérologie de l'Ouest ROLLAND Frederic - - / Non 16/11/2018
Afficher les détails
Acronyme : "CR107947 63935937MDS3001 2015-002874-19
Spécialité : Hématologie
Traitement : Protocole de traitement
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Titre :

A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Critères d'inclusion : Critères de non-inclusion :
Centres investigateurs

Afficher les détails

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