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Brief Title: A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Official Title: A Phase 2, Open-Label Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Study ID: NCT02042378
Brief Summary: The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.
Detailed Description: Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) that inhibits a specific DNA repair pathway known as base excision repair (BER). PARP inhibitors (PARPi) have been shown to effectively kill tumors with a defect in BRCA1 or BRCA2. Clinical benefit has been observed in patients with a gBRCA mutation as well as in those with a somatic BRCA (sBRCA) mutation. Clinical data have also shown that pancreatic cancer patients with a gBRCA mutation benefit from PARPi treatment. Clinical activity of PARP inhibitors in BRCA-mutated pancreatic cancer combined with the paucity of 2nd line therapies support evaluation of rucaparib in pancreatic cancer patients known to harbor a deleterious BRCA mutation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cedars Sinai Medical Center, Los Angeles, California, United States
Mayo Clinic, Rochester, Minnesota, United States
New York University, New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Rambam Healthcare Campus, Haifa, , Israel
Hadassah Hebrew University Hospital (Sharett Institute of Oncology), Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Name: Heidi Giordano
Affiliation: Clovis Oncology, Inc.
Role: STUDY_DIRECTOR