Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1)

I3Y-MC-JPCY -

The purpose of this study is to evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Prostate Cancer
What the trial is testing?
Abemaciclib
Could I receive a Placebo?
No
Enrollment Goal
44
Trial Dates
Jan 20, 2021 - Jun 2, 2023
How long will I be in the trial?
Your participation could last up to 12 months depending on how you and your tumor respond.
Trial Phase
II

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:

  • 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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