Status:
COMPLETED
Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metastatic Castration-Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04408924
Start Date
January 20 2021
End Date
June 2 2023
Last Update
June 25 2024
Active Locations (14)
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1
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
2
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
3
Centre Leon Berard
Lyon, France, 69373
4
Institut Paoli-Calmettes
Marseille, France, 13273