A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)

Status: Recruiting
Phase: Phase 2
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01891344 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-496


The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Cesar Castro, MD, Massachusetts General Hospital

Site-responsible Investigators:
Panagiotis Konstantinopoulos, MD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

Inclusion Criteria: - Confirmed diagnosis of high-grade epithelial ovarian (serous or endometrioid histology), fallopian tube, or primary peritoneal cancer - Relapsed/progressive disease as confirmed by CT scan - Received ≥1 prior platinum-based treatment regimen - Received platinum-based regimen as last treatment; continuous or switch maintenance treatment as part of this regimen is permitted - Sensitive to last platinum regimen (disease progression >6 months after the last dose of platinum) - If <55 years of age at diagnosis, prior history of breast cancer, or close relative (first or second degree) with ovarian cancer or early onset (<age 50) breast cancer, must have been previously tested for gBRCA mutation - Have biopsiable and measurable disease Exclusion Criteria: - History of prior cancer except for non-melanoma skin cancer, curatively treated solid tumor (>5 years ago without evidence of recurrence) or curatively treated breast cancer (>3 years ago without evidence of recurrence) - Prior treatment with any PARP inhibitor - Symptomatic and/or untreated central nervous system metastases - Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption of rucaparib
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