| 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 |
ARIEL4 |
| ClinicalTrials.gov ID |
NCT02855944 |
| Type(s) de cancer |
Ovaire |
| Phase |
Phase III |
| Stade |
Maladie réfractaire |
| Type étude |
Traitement |
| Médicament |
Rucaparib |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Susie Lau
|
| Coordonnateur(trice) |
Heather Gregory
514-340-8222 poste 24596
|
| Statut |
![]() Fermé |
| 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