Breast Cancer Clinical Trial
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
Summary
A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in patients with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.
Eligibility Criteria
Key Inclusion Criteria:
Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive disease
Measurable disease per RECIST v1.1 or modified RECIST v1.1 and PCWG3 (for prostate cancer)
Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: Breast cancer patients that are HER2 negative and have germline BRCA1 or BRCA2 mutations AND patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutations are ineligible for this trial.
At least one prior line of therapy extending overall survival or standard of care therapy for advanced disease. Note: Some tumor types have specific inclusion/exclusion criteria for previous treatments.
ECOG 0 or 1
Tumor tissue available for genomic analysis, or must be willing to have a biopsy if no archival tumor tissue available
Adequate organ function
Life expectancy of 4 months
Key Exclusion Criteria:
Active central nervous system brain metastases, leptomeningeal disease or primary tumor of CNS origin
Active second malignancy (Exceptions: Successfully treated malignancy with no active disease for 1 year, surgically cured and/or low-risk tumors, or patients receiving ongoing anticancer hormonal therapy for a previously treated cancer)
Pre-existing gastrointestinal disorders/conditions interfering with ingestion/absorption of rucaparib
Prior treatment with a PARP inhibitor
More than 3 prior lines of chemotherapy in the locally advanced/metastatic setting
History of myelodysplastic syndrome or acute myeloid leukemia
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There are 18 Locations for this study
Los Angeles California, 90024, United States
San Francisco California, 94158, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Iowa City Iowa, 52242, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Bronx New York, 10469, United States
New York New York, 10032, United States
Port Jefferson Station New York, 11776, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15232, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Seattle Washington, 98109, United States
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