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.
Primary Objective: 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 Secondary Objectives: 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); DOR; Disease Control Rate (DCR), defined as the percentage of CRs, PRs, and SDs greater than 16 weeks; PFS; Overall survival (OS); To evaluate the safety and tolerability of rucaparib; To evaluate steady-state pharmacokinetics (PK) of rucaparib.
AG-014447 (Rucaparib); CO-338 (Rucaparib); Not Applicable (); PF-01367338-BW (Rucaparib); Rucaparib ()
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