Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
Completed · Phase 2
Conditions studied: Metastatic Castration-Resistant Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT04408924
- Run by
- Eli Lilly and Company
- People needed
- 44
- Starts
- 2021-01-20
- Expected to finish
- 2023-06-02
- Last updated by the study team
- 2024-06-25
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Centre Leon Berard — Lyon, France
- Institut Paoli-Calmettes — Marseille, France
- Hopital Europeen Georges Pompidou — Paris, France
- Institut Claudius Regaud — Toulouse, France
- Gustave Roussy — Villejuif, France
- Institut Catala d'Oncologia — L'Hospitalet de Llobregat, Barcelona, Spain
- Corporacion Sanitaria Parc Tauli — Sabadell, Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Hospital General Universitario Gregorio Maranon — Madrid, Spain
- Hospital Universitario Ramon y Cajal — Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
Full record on ClinicalTrials.gov
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