A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Radiographic Progression Free Survival (rPFS) — From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.
Trial sites (112)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Eli Lilly and Company trials in Spain
Other trials for the same condition
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 Spain