Titre |
A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
Protocole ID |
CO-338-043 (ARIEL4) |
ClinicalTrials.gov ID |
NCT02855944 |
Type(s) de cancer |
Ovaire |
Phase |
Phase III |
Stade |
Maladie réfractaire |
Type étude |
Traitement |
Médicament |
Rucaparib |
Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dre Diane Provencher
|
Coordonnateur(trice) |
Shirley Truchon
514-890-8000 poste 25350
|
Statut |
Fermé |
Date d'activation |
08-03-2017 |
Critètes d'éligibilité |
- Be 18 years of age at the time the informed consent form is signed
- Have a histologically confirmed Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
- Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation
- Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
|
Critètes d'exclusion |
- History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib).
- Prior treatment with any PARP inhibitor
- Symptomatic and/or untreated central nervous system metastases
- Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
- Women who are pregnant or breast feeding
- Hospitalization for bowel obstruction within 3 months prior to enrollment
|