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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03706365

Run by

Eli Lilly and Company

People needed

393

Starts

2018-11-26

Expected to finish

2026-12-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States
• The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States
• St. Bernards Medical Center — Jonesboro, Arkansas, United States
• CBCC Global Research, Inc. — Bakersfield, California, United States
• Providence St. Jude Medical Center — Fullerton, California, United States
• Moores Cancer Center — La Jolla, California, United States
• TRIO-US (Translational Research in Oncology-US) — Los Angeles, California, United States
• UCLA Hematology/Oncology - Westwood (Building 100) — Los Angeles, California, United States
• Pacific Cancer Care — Monterey, California, United States
• Sansum Clinic_Kendle — Santa Barbara, California, United States
• Rocky Mountain Cancer Center — Lone Tree, Colorado, United States
• Millennium Oncology - Hollywood — Hollywood, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center — Fort Wayne, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• M Health Fairview University of Minnesota Medical Center - East Bank — Minneapolis, Minnesota, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• New York Oncology Hematology (NYOH) - Clifton Park Cancer Center — Albany, New York, United States
• Associated Medical Professionals - Urology — Syracuse, New York, United States
• Research Medical Center — Nashville, Tennessee, United States
• Baylor Scott & White Medical Center - Temple — Temple, Texas, United States
• New York Oncology Hematology (NYOH) - Clifton Park Cancer Center — The Woodlands, Texas, United States
• Northwest Cancer Specialists PC — The Woodlands, Texas, United States
• Sansum Clinic_Kendle — The Woodlands, Texas, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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