drugset / Trial / NCT05288166

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

NCT05288166

Phase 3 Active not recruiting 925 enrolled Eli Lilly and Company
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

Timeline

Start
2022-04-14
Primary completion
2024-02-15
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 200 mg Oral
Background Abiraterone acetate Small molecule 1000 mg Oral
Background Prednisolone Other / unclassified 5 mg Oral
Background Prednisone Other / unclassified 5 mg Oral