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

Source: https://onco.cc/trials/nct03706365/  
OnCo record `nct03706365` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial of Abemaciclib, Abiraterone acetate, Prednisone in prostate cancer, run by Eli Lilly and Company, active and no longer recruiting.

## Summary

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer is a phase 2/3 interventional study registered as NCT03706365 by Eli Lilly and Company, with 393 participants enrolled, started 2018-11-26 and due to reach its primary completion in 2024-01-02. Interventions recorded: Abemaciclib, Placebo, Abiraterone acetate, Prednisone. Conditions listed: Prostate Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: CYCLONE 2
- Tags: ctgov-ingest
- Registry id: NCT03706365
- Phase: 2/3
- Setting: 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
- Sponsor: Eli Lilly and Company
- Enrolled: 393
- Outcomes: Radiographic Progression Free Survival (rPFS): Abemaciclib 21.96 months vs Placebo 20.28 months, HR 0.829; Overall Survival (OS): Abemaciclib 38.01 months vs Placebo 33.21 months, HR 0.927; Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR): Abemaciclib 45.2% vs Placebo 54.8%

## Sources

- ClinicalTrials.gov NCT03706365: https://clinicaltrials.gov/study/NCT03706365

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/), [CDK4/6 inhibitors](https://onco.cc/technologies/cdk46-inhibitor/)
- drugs: [Abemaciclib](https://onco.cc/drugs/abemaciclib/), [Abiraterone acetate](https://onco.cc/drugs/abiraterone/), [Prednisone](https://onco.cc/drugs/prednisone/)
- companies: [Eli Lilly (incl. Loxo)](https://onco.cc/companies/eli-lilly/)
- key papers: [Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial](https://onco.cc/key-papers/paper-nct03706365-lancet-oncol-2025/)

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