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

Trial Status: Closed to Accrual

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.

Inclusion Criteria

  • The following eligibility criteria pertain to patients enrolling into PART 2 of the study: Inclusion: - Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer - Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen - Relapsed/progressive disease as confirmed by CT scan - Have biopsiable and measurable disease. Note: biopsy is optional for patients known to harbor a deleterious gBRCA mutation - Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses 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 - Hospitalization for bowel obstruction within 3 months prior to enrollment

Arizona

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

California

Los Angeles
Translational Oncology Research International
Status: ACTIVE
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

Florida

Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Panagiotis A. Konstantinopoulos
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
University of Pennsylvania / Abramson Cancer Center
Status: CLOSED_TO_ACCRUAL
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: COMPLETED

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: COMPLETED

Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations. Clinical data with PARP inhibitors indicate there is an ovarian cancer patient population beyond just those with germline BRCA (gBRCA) mutations that may benefit from treatment with a PARP inhibitor. This study will define a molecular signature of HRD in ovarian cancer that correlates with response to rucaparib and enables selection of appropriate ovarian cancer patients for treatment with rucaparib. The HRD signature will be based on an association between the extent of genomic scarring (a downstream consequence of HRD) in a patient's tumor and observed clinical benefit from rucaparib treatment. Genomic scarring can be assessed by quantifying the extent of loss of heterozygosity across the tumor genome (tumor genomic LOH). One of the main advantages of detecting tumor genomic LOH is that it can identify HRD tumors regardless of the underlying mechanisms, which include both known (i.e., BRCA mutations) and unknown genetic and other mechanisms. Once determined, this signature will be prospectively applied to ARIEL2 PART 2 and ARIEL3. This Phase 2 study (ARIEL2) will also compare archival versus recently collected tumor tissue in order to validate the use of archival tumor tissue for assessment of HRD status in ARIEL3. This study will include 2 parts: PART 1 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received ≥1 prior platinum-based regimen and had platinum-sensitive disease PART 2 (currently enrolling): Evaluation of HRD status and rucaparib efficacy in patients who received at least 3 prior chemotherapy regimens

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Clovis Oncology

  • Primary ID CO-338-017
  • Secondary IDs NCI-2013-01733, S13-00035
  • Clinicaltrials.gov ID NCT01891344