Ovaire

TITRE	Étude multicentrique à répartition aléatoire de phase III visant à comparer le rucaparib à la chimiothérapie chez des patientes atteintes d’un cancer épithélial de l’ovaire récidivant de haut grade avec mutation BRCA, d’un cancer des trompes de Fallope ou d’un cancer péritonéal primitif
PROTOCOLE ID	CO-338-043 (ARIEL4)
CLINICAL TRIAL.gov ID	NCT02855944
TYPE(S) DE CANCER	Ovaire
PHASE	Phase III
TYPE D'ÉTUDE	Traitement
INSTITUTION	CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE 3001 12e Avenue Nord (819) 346-1110
VILLE	Sherbrooke
INVESTIGATEUR(RICE) PRINCIPAL(E)	Paul Bessette
COORDONATEUR(RICE)	Annie Bourbonnais annie.bourbonnais.ciussse-chus@ssss.gouv.qc.ca 819-346-1110 poste 12890
STATUT	Fermé
CRITÈRES D'ÉLIGIBILITÉ	(EN) 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
CRITÈRES D'EXCLUSION	(EN) 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