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

  • STATUS
    Recruiting
  • End date
    Jul 18, 2023
  • participants needed
    40
  • sponsor
    Eli Lilly and Company
Updated on 22 September 2021
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
Institut Claudius Regaud - IUCT Oncopole (0.0 mi away) Contact
+21 other location

Summary

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

Details
Condition Metastatic Castration Resistant Prostate Cancer
Treatment Abemaciclib
Clinical Study IdentifierNCT04408924
SponsorEli Lilly and Company
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must have metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant)
Participant must have disease spread to soft tissue that is measurable
Participant must have documented evidence of progressive disease by PSA test or imaging
Participant must have previously received at least one of the following treatment: abiraterone acetate, apalutamide, darolutamide or enzalutamide
Participant must have previously received chemotherapy with docetaxel and cabazitaxel
Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research
Participant must have good physical functioning ability and adequate organ function

Exclusion Criteria

Participant must not have received more than 3 therapy regimens for metastatic castration-resistant prostate cancer (NOTE: GnRHa, first-generation antiandrogens (flutamide, nilutamide, or bicalutamide), diethylstilbestrol (DES) (or other estrogens), corticosteroids, ketoconazole, and bone loss-prevention will not count as systemic therapy regimens
Participants must not have previously received abemaciclib or any cyclin-dependent kinase (CDK)4 and/or CDK6 inhibitors
Participants must not have serious and/or uncontrolled preexisting medical condition(s) including but not limited to severe renal impairment, severe hepatic impairment, interstitial lung disease (ILD)/pneumonitis, severe dyspnea at rest or requiring oxygen therapy or other serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
Participants must not have, or suspected to have, brain metastasis
Participants must not have untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression or structurally unstable bone lesions suggesting impending fracture
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