A Phase 2 Multicenter, Open-label Study of rucaparib as treatment for Solid tumors associated with Deleterious Mutations in Homologous Recombination Repair Genes.
Trial Description
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.
Eligibility Requirements
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