A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated with Deleterious Mutations in Homologous Recombination Repair Genes (LODESTAR)
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.
To determine the objective response rate (ORR), as assessed by the investigator, by RECIST v1.1 (or by RECIST v1.1 and Prostate Cancer Working Group Guidelines Version 3 [PCWG3] criteria in patients with mCRPC).
[Rucaparib (CO-338)] Clovis Oncology Clinical Study Protocol: CO-338-100 Amendment 2 27 February 2020 Confidential Page 14 of 118
Objective response rate (ORR) as assessed by independent radiology review (IRR) by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in patients with mCRPC);
Disease Control Rate (DCR), defined as the percentage of CRs, PRs, and SDs greater than 16 weeks;
Overall survival (OS);
To evaluate the safety and tolerability of rucaparib;
To evaluate steady-state pharmacokinetics (PK) of rucaparib.
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
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
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