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- W2891034980 abstract "e17028 Background: Ribociclib is a potent and selective cyclin-dependent kinase (CDK) 4/6 inhibitor with significant pre-clinical activity in enzalutamide-resistant prostate cancer cell lines. Prior pre-clinical studies have demonstrated synergy with taxane chemotherapy. We conducted a multi-institutional phase 1b study to evaluate the safety and preliminary efficacy of ribociclib in combination with docetaxel in patients (pts) with mCRPC. Methods: Pts with mCRPC with prior progression on abiraterone and/or enzalutamide, and no prior chemotherapy for mCRPC were eligible. Dose escalation utilized a 3+3 design with escalating doses of ribociclib starting at 200 mg daily in combination with docetaxel 75 mg/m2, with mandatory G-CSF prophylaxis. The primary objective was to determine the maximally tolerated and recommended phase 2 dose (RP2D). Secondary objectives included pharmacokinetics (PK), PSA50 response rate (≥ 50% decline from baseline in PSA), and objective response rate (ORR). Results: 14 pts were enrolled, with a median age of 68 (55-80) and baseline PSA of 206 (40-1714). 2 dose limiting toxicities (DLTs) (febrile neutropenia and grade 4 neutropenia) were observed at the starting dose/schedule. Using an alternative dosing schema with docetaxel 60 mg/m2 and ribociclib days 1-4 and 8-15, with G-CSF support on days 5-7, no further DLTs were observed. Most common grade ≥ 3 AEs included neutropenia (64%) and febrile neutropenia (14%). Reasons for treatment discontinuation included disease progression (N = 7), adverse event (N = 5), and study withdrawal (N = 1); one pt remains on treatment. PSA50 response rate was 29% among 14 evaluable pts. PK analyses demonstrated a modest and predictable impact of ribociclib on docetaxel clearance. The RP2D is ribociclib 400 mg daily in combination with docetaxel 60 mg/m2. Conclusions: With intermittent dosing and G-CSF support, combining ribociclib with docetaxel chemotherapy is feasible with neutropenia as the most commonly observed AE. A phase 2 study of the combination will further assess efficacy and safety. Clinical trial information: NCT02494921." @default.
- W2891034980 created "2018-09-27" @default.
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- W2891034980 date "2018-05-20" @default.
- W2891034980 modified "2023-09-27" @default.
- W2891034980 title "c15-149: A phase 1b study of the oral CDK4/6 inhibitor ribociclib in combination with docetaxel plus prednisone in metastatic castration resistant prostate cancer (mCRPC)—A prostate cancer clinical trials consortium study." @default.
- W2891034980 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.e17028" @default.
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