A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

Phase 2/3 Active not recruiting 393 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2018-11-26
Primary completion: 2024-01-02
Completion: 2026-06

Outcome

Missed primary endpoint

paper The primary endpoint of radiographic progression-free survival was not met: PMID 41167216 ↗

registry analysis (other test); Abemaciclib vs Placebo; p = 0.2123; Hazard Ratio (HR) 0.829 (95% CI 0.619 to 1.111); Log Rank NCT03706365 ↗

Publications

Smith M, Piulats J, Todenhofer T, Lee JL, Arija JA, Mazilu L, Azad A, Alonso-Gordoa T, McGovern U, Choudhury A, Horvath L, Ye D, Han W, Suzuki H, Uemura H, McKay R, Ades S, Flechon A, Pieczonka C, Fernandes MS, Hulstijn M, Lithio A, Nacerddine K, Agarwal N; CYCLONE 2 investigators. Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2025 Nov;26(11):1489-1500. doi: 10.1016/S1470-2045(25)00475-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abemaciclib	Small molecule	150 mg	Oral
Subject	Abemaciclib	Small molecule	200 mg	Oral
Background	Abiraterone acetate	Small molecule	1000 mg	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral