A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date: November 27, 2018
Estimated Primary Completion Date: September 15, 2021
Estimated Study Completion Date: February 14, 2024
Arm:
- Experimental: A1. Abiraterone plus Prednisone and Abemaciclib
- Experimental: A2. Abiraterone plus Prednisone and Abemaciclib
- Active Comparator: B1. Abiraterone plus Prednisone and Placebo
- Active Comparator: B2. Abiraterone plus Prednisone and Placebo
- Experimental: A. Abiraterone plus Prednisone and Abemaciclib
- Active Comparator: B. Abiraterone plus Prednisone and Placebo
| Category | Value |
|---|---|
| Date last updated at source | 2019-04-17 |
| Study type(s) | Interventional |
| Expected enrolment | 180 |
| Study start date | 2018-11-27 |
| Estimated primary completion date | 2021-09-15 |