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Clinical Trials in China / NCT03706365
Active, not recruiting Phase 2/3

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

NCT03706365 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2/3
Started
2018-11-26
Last updated
2026-08-07

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

AbemaciclibPlaceboAbiraterone acetatePrednisone

Abemaciclib: Administered orally.

Placebo: Administered orally.

Abiraterone acetate: Administered orally.

Prednisone: Administered orally.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (112)

FacilityCityRegionStatus
St. Joseph's Hospital and Medical Center Phoenix Arizona
Mayo Clinic in Arizona - Phoenix Phoenix Arizona
The University of Arizona Cancer Center - North Campus Tucson Arizona
St. Bernards Medical Center Jonesboro Arkansas
CBCC Global Research, Inc. Bakersfield California
Providence St. Jude Medical Center Fullerton California
Moores Cancer Center La Jolla California
TRIO-US (Translational Research in Oncology-US) Los Angeles California
UCLA Hematology/Oncology - Westwood (Building 100) Los Angeles California
Pacific Cancer Care Monterey California
Sansum Clinic_Kendle Santa Barbara California
Rocky Mountain Cancer Center Lone Tree Colorado
Millennium Oncology - Hollywood Hollywood Florida
Northside Hospital Atlanta Georgia
Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center Fort Wayne Indiana
Massachusetts General Hospital Boston Massachusetts
M Health Fairview University of Minnesota Medical Center - East Bank Minneapolis Minnesota
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center Albany New York
Associated Medical Professionals - Urology Syracuse New York
Research Medical Center Nashville Tennessee
Baylor Scott & White Medical Center - Temple Temple Texas
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center The Woodlands Texas
Northwest Cancer Specialists PC The Woodlands Texas
Sansum Clinic_Kendle The Woodlands Texas
Texas Oncology - Longview Cancer Center The Woodlands Texas
Texas Oncology Cancer Care and Research Center The Woodlands Texas
Texas Oncology Fort Worth The Woodlands Texas
Texas Oncology-Memorial City The Woodlands Texas
US Oncology The Woodlands Texas
USO-Cancer Care Center of Brevard, Inc. The Woodlands Texas
Huntsman Cancer Institute Salt Lake City Utah
The University of Vermont Medical Center Inc. Burlington Vermont
Chris O'Brien Lifehouse Camperdown New South Wales
Southside Cancer Care Centre Kogarah New South Wales
Macquarie University Macquarie University New South Wales
Prince of Wales Hospital Randwick New South Wales
Peter MacCallum Cancer Centre Melbourne Victoria
St Vincent's Hospital Melbourne Victoria
Second Affiliated hospital of Anhui Medical University Hefei Anhui

+ 72 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile → 📄 Deltasone (prednisone) drug profile →

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03706365 on ClinicalTrials.gov ↗ ← All trials in China