Completed Enrollment

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer (CYCLONE 2)

I3Y-MC-JPCM -

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 resistantprostate cancer.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Prostate Cancer
What the trial is testing?
Abemaciclib, Abiraterone Acetate, Prednisone
Could I receive a Placebo?
Yes
Enrollment Goal
350
Trial Dates
Nov 26, 2018 - Jun 2026
How long will I be in the trial?
Your participation in this trial could last up to 40 months, depending on how you and your tumor respond.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have diagnosis of prostate cancer that is metastatic

  • Participant must have prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant)

  • Participant must have documented evidence of progressive disease by imaging and/or PSA test

  • Participant must be willing to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research

Participants Must Not:

  • Participant must not have received any of the following prior therapies: abiraterone acetate, abemaciclib, chemotherapy in the castration-resistant setting, radiopharmaceuticals, enzalutamide, apalutamide, darolutamide or sipuleucel-T

  • Participants must not have conditions that are not compatible with the clinical trial participation such as inability to swallow large pills, active or chronic liver disease, clinically significant heart disease, HIV, AIDS, active or uncontrolled clinically serious infection, or uncontrolled hypertension

  • Participant must not have brain metastases

  • Participant of reproductive potential must not father a child and must agree to use medically approved contraceptive precautions, and not donate sperm, during the study and for three months following the last dose of study drug

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