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A Study of Abiraterone Acetat...

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

Last Updated: 2025-04-20

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Abemaciclib

Participants received 200 milligrams (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally.

Abiraterone acetate

Intervention Type DRUG

Administered orally.

Prednisone

Intervention Type DRUG

Administered orally.

Placebo

Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Abiraterone acetate

Intervention Type DRUG

Administered orally.

Prednisone

Intervention Type DRUG

Administered orally.

Interventions

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Abemaciclib

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Abiraterone acetate

Administered orally.

Intervention Type DRUG

Prednisone

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY2835219

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

Site Status

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

Site Status

St. Bernards Medical Center

Jonesboro, Arkansas, United States

Site Status

CBCC Global Research, Inc.

Bakersfield, California, United States

Site Status

Providence St. Jude Medical Center

Fullerton, California, United States

Site Status

Moores Cancer Center

La Jolla, California, United States

Site Status

TRIO-US (Translational Research in Oncology-US)

Los Angeles, California, United States

Site Status

UCLA Hematology/Oncology - Westwood (Building 100)

Los Angeles, California, United States

Site Status

Pacific Cancer Care

Monterey, California, United States

Site Status

Sansum Clinic_Kendle

Santa Barbara, California, United States

Site Status

Rocky Mountain Cancer Center

Lone Tree, Colorado, United States

Site Status

Millennium Oncology - Hollywood

Hollywood, Florida, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center

Fort Wayne, Indiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

New York Oncology Hematology (NYOH) - Clifton Park Cancer Center

Albany, New York, United States

Site Status

Associated Medical Professionals - Urology

Syracuse, New York, United States

Site Status

Research Medical Center

Nashville, Tennessee, United States

Site Status