Data from clinicaltrials.gov - Curated by EPG Health - Last updated 29 April 2019

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.

purpose

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 17-Apr-19
Study type(s) Interventional
Expected enrolment 180
Study start date 27-Nov-18
Estimated primary completion date 15-Sep-21

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