| TITRE |
(EN) 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 |
ARIEL4 |
| CLINICAL TRIAL.gov ID |
NCT02855944 |
| TYPE(S) DE CANCER |
Ovaire |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Traitement |
| INSTITUTION |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
3755 rue de la Côte Ste. Catherine
(514) 340-8222
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Susie Lau
|
| COORDONATEUR(RICE) |
Heather Gregory
heather.gregory.ccomtl@ssss.gouv.qc.ca
514-340-8222 poste 24596
|
| 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
|
