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

NCT03706365 · CYCLONE 2 Phase 2/3Active, not recruiting

Lead sponsor
Eli Lilly and Company (Industry)
Enrollment
393 (actual)
Start date
26 Nov 2018
Primary completion
2 Jan 2024 (actual)
Study completion
1 Dec 2026
Last update posted
7 Aug 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
2

Interventions

  • Abemaciclib Drug
  • Placebo Drug
  • Abiraterone acetate Drug
  • Prednisone Drug

Conditions and primary outcome

  • Prostate Cancer

Primary outcome

Radiographic Progression Free Survival (rPFS) (From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03706365 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Radiographic Progression Free Survival (rPFS)

    Time frame
    From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
    Measure
    Median
    Unit
    Months

    • Abemaciclib vs PlaceboOther

      Estimate
      0.829Hazard Ratio (HR)
      95% CI, two-sided
      0.619 to 1.111
      p-value
      0.2123
      Method
      Log Rank

Serious adverse events

Time frame: Baseline Up to 60 Months

Participants with serious adverse events per group for CYCLONE 2, as posted
GroupAffectedAt risk
Abemaciclib89206
Placebo66185

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

1 on PubMed

  1. Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial.

    The Lancet. Oncology · 2025 Nov

    PubMed 41167216 (opens in a new tab)DOI 10.1016/S1470-2045(25)00475-9 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.