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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2026
  • participants needed
    350
  • sponsor
    Eli Lilly and Company
Updated on 1 August 2021
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
Macquarie University Hospital (1.3 mi away) Contact
+130 other location
prednisone
androgens
progressive disease
bone scan
abiraterone
metastatic prostate cancer
orchiectomy
adenocarcinoma
adenocarcinoma of prostate
prostate cancer metastatic

Summary

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 resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment prednisone, Placebo, abiraterone acetate, Abemaciclib
Clinical Study IdentifierNCT03706365
SponsorEli Lilly and Company
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate
Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI)
Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following
PSA progression
Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression
Have adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion Criteria

Prior therapy with cytochrome P450 (CYP)17 inhibitors
Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors
Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer [mHSPC] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions
Currently enrolled in a clinical study involving an investigational product
Gastrointestinal disorder affecting the absorption or ability to swallow large pills
Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C)
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