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
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
This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
Inclusion Criteria:
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:
Have adequate organ function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Exclusion Criteria:
Fort Wayne, Indiana 46804, United States
Minneapolis, Minnesota 55455, United States
Albany, New York 12206, United States
The Woodlands, Texas 77380, United States
Macquarie University, New South Wales 2109, Australia
Luoyang, Henan 471003, China
Nanjing, Jiangsu 210000, China
Cologne, North Rhine-Westphalia 50968, Germany
Münster, North Rhine-Westphalia 48149, Germany
Ina-machi, Saitama 362-0806, Japan
Shinagawa, Tokyo 142-8555, Japan
Seoul, Seoul-teukbyeolsi [Seoul] 3722, South Korea
Songpagu, Seoul-teukbyeolsi [Seoul] 5505, South Korea
Hospitalet, Barcelona [Barcelona] 8907, Spain