I3Y-MC-JPCM: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer - I3Y-MC-JPCM

Eli Lilly & Co.0 个研究点目标入组 304 人开始时间: 2024年1月10日最近更新: 2024年7月22日

适应症

试验速览

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•Histologically confirmed adenocarcinoma of the prostate., Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI)., Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following: PSA progression, Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression, Have adequate organ function., Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

•Prior therapy with cytochrome P450 (CYP)17 inhibitors., Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors., Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer [mHSPC] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions., Currently enrolled in a clinical study involving an investigational product., Gastrointestinal disorder affecting the absorption or ability to swallow large pills., Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).

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