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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

83

Study ID:

NCT04171700

Recruitment Status:

Terminated

Sponsor:

pharmaand GmbH

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There are 18 Locations for this study

See Locations Near You

UCLA Medicine Hematology and Oncology
Los Angeles California, 90024, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago Illinois, 60611, United States
University of Iowa Hospital and Clinics
Iowa City Iowa, 52242, United States
Beth Israel Deaconess Medical Cancer Surgical Pavilion
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
New York Cancer And Blood Specialists
Bronx New York, 10469, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
New York Cancer and Blood Specialists
Port Jefferson Station New York, 11776, United States
Ohio State University
Columbus Ohio, 43210, United States
Stephenson Cancer Center - The University of Oklahoma
Oklahoma City Oklahoma, 73104, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
SCRI/Tennessee Oncology - Chattanooga
Chattanooga Tennessee, 37404, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Seattle Cancer Care Alliance/University of Washington
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

83

Study ID:

NCT04171700

Recruitment Status:

Terminated

Sponsor:


pharmaand GmbH

How clear is this clinincal trial information?

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