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Spots Global Cancer Trial Database for A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation

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Trial Identification

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

Interventions

Rucaparib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Heidi Giordano

Affiliation: Clovis Oncology, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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