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A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
Sponsor: Eli Lilly and Company
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.
Official title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
393
Start Date
2018-11-26
Completion Date
2026-06
Last Updated
2025-04-20
Healthy Volunteers
No
Conditions
Interventions
Abemaciclib
Administered orally.
Placebo
Administered orally.
Abiraterone acetate
Administered orally.
Prednisone
Administered orally.
Locations (112)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
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
Texas Oncology - Longview Cancer Center
The Woodlands, Texas, United States
Texas Oncology Cancer Care and Research Center
The Woodlands, Texas, United States
Texas Oncology Fort Worth
The Woodlands, Texas, United States
Texas Oncology-Memorial City
The Woodlands, Texas, United States
US Oncology
The Woodlands, Texas, United States
USO-Cancer Care Center of Brevard, Inc.
The Woodlands, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Southside Cancer Care Centre
Kogarah, New South Wales, Australia
Macquarie University
Macquarie University, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
Second Affiliated hospital of Anhui Medical University
Hefei, Anhui, China
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China
Lanzhou university second hospital
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Centre
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
Wuhan Union Hospital
Wuhan, Hubei, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Province People's Hospital
Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated Fudan University
Shanghai, Shanghai Municipality, China
Nanchong Central Hospital
Nanchong, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Cancer Hospital - Urumqi
Ürümqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Rigshospitalet
Copenhagen, Capital Region, Denmark
Næstved Sygehus
Næstved, Region Sjælland, Denmark
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-Roussillon, France
Clinique Victor Hugo Le Mans
Le Mans, Pays de la Loire Region, France
CHD Vendee
La Roche-sur-Yon, Vendée, France
CHU de Bordeaux Hop St ANDRE
Bordeaux, France
Henri Mondor Hospital
Créteil, Île-de-France Region, France
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Gesundheitszentrum Holzminden
Holzminden, Lower Saxony, Germany
Studienzentrum Bayenthal Urologische Partnerschaft Köln
Cologne, North Rhine-Westphalia, Germany
Urologie Neandertal - Praxis Mettmann
Mettmann, North Rhine-Westphalia, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany
Private Practice - Dr. Stammel & Dr. Garcia
Wesel, North Rhine-Westphalia, Germany
Private Practice - Dr. Silvio Szymula
Leipzig, Saxony, Germany
Private Practice - Dr. Ralf Eckert
Eisleben Lutherstadt, Saxony-Anhalt, Germany
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Saitama Prefectural Cancer Center
Ina-machi, Saitama, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Showa University Hospital
Shinagawa, Tokyo, Japan
Gifu University Hospital
Gifu, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Osaka International Cancer Institute
Osaka, Japan
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, Netherlands
Ovidius Clinical Hospital OCH
Ovidiu, Constanța County, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Gral Medical Diagnostic Center
Bucharest, Romania
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Songpagu, Seoul-teukbyeolsi [Seoul], South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, Barcelona [Barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain