A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.
Checked against the public recordLast updated Oct 2, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- pharmaand GmbH
- Interventions being studied
- Drug: Rucaparib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Medicine Hematology and OncologyLos Angeles, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Florida Cancer SpecialistsFort Myers, Florida
- Florida Cancer SpecialistsSt. Petersburg, Florida
- H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida
- Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicago, Illinois
- University of Iowa Hospital and ClinicsIowa City, Iowa
- Beth Israel Deaconess Medical Cancer Surgical PavilionBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- Columbia University Irving Medical CenterNew York, New York
- New York Cancer and Blood SpecialistsPort Jefferson Station, New York
- New York Cancer And Blood SpecialistsThe Bronx, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 2, 2023. Always confirm current availability with the study team.