A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Treatments: Rucaparib

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