| 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 |
| Type étude |
Traitement |
| Médicament |
Rucaparib |
| Institution |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
 HOPITAL FLEURIMONT
3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
|
| Ville |
Sherbrooke |
| Investigateur(trice) principal(e) |
Dr Paul Bessette
|
| Coordonnateur(trice) |
Annie Bourbonnais
819-346-1110 poste 12890
|
| Statut |
 Actif en recrutement |
| 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
|
Groupe d'étude en oncologie du Québec