A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in… (NCT04171700) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
Stopped: The study was terminated due to a change in development priorities.
United States83 participantsStarted 2020-01-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/absorptio…
What they're measuring
1
Best Overall Response Rate by Investigator
Timeframe: From first dose of study drug until disease progression (up to approximately 2 years)