A study of abiraterone acetate plus prednisone with or without abemaciclib (LY2835219) in participants with prostate cancer (CYCLONE 2)
A study of abiraterone acetate plus prednisone with or without abemaciclib (LY2835219) in participants with prostate cancer (CYCLONE 2)
ClinicalTrials.gov ID: NCT03706365
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company (Responsible Party)
Last Update Posted: 2024-10-18
Brief Summary:
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.
Official Title:
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
Intervention / Treatment:
- Drug: Abemaciclib
- Drug: Abiraterone Acetate
- Drug: Prednisone
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2018-11-26
|
| Primary Completion (Actual) |
2024-01-02
|
| Study Completion (Estimated) |
2026-06-01
|
| Enrollment (Estimated) | 350 |
| Study Type | Interventional |
| Phase | Phase 2 Phase 3 |
| Other Study ID Numbers |
16598
I3Y-MC-JPCM (Other Identifier) (OTHER: Eli Lilly and Company) 2016-004276-21 (EudraCT Number) |