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Extrait
Dose Escalation: Characterize the safety/tolerability of GS-5829 as a single agent and in combination with enzalutamide (enz) in subjects with mCRPC; determine the MTD of GS-5829 as a single agent and in combination with enz in subjects with mCRPC Dose Expansion: Grp 1: Evaluate the efficacy of GS-5829 as a single agent in subjects with mCRPC who have progressed while receiving enz (may have also received abiraterone (abt)) as measured by Progression Rate (PR) at Wk 24 according to PCWG2; Grp 2: Evaluate the efficacy of GS-5829 combined with enz in subjects with mCRPC who have progressed while receiving treatment with abt (subjects may not have previously received enz) as measured by PR at Wk 24 according to PCWG2; Grp 3: Evaluate the efficacy of GS-5829 combined with enz in subjects with mCRPC who have had PSA progression, but not radiographic progression, while receiving treatment with enz (may have also previously received abt), as measured by PR at Wk 24 according to PCWG2.
Critère d'inclusion
- Metastatic Castrate-Resistant Prostate Cancer