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Brief Title: A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
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
Study ID: NCT03706365
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
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
Maryland Oncology Hematology - Columbia, Columbia, Maryland, 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
Northwest Cancer Specialists PC, 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, China
Huashan Hospital Affiliated Fudan University, Shanghai, Shanghai, China
Nanchong Central Hospital, Nanchong, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
The Second Hospital of Tianjin Medical University, Tianjin, Tianjin, China
Xinjiang Medical University Cancer Hospital - Urumqi, Urumqi, 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, Hovedstaden, Denmark
Næstved Sygehus, Næstved, Sjælland, Denmark
Centre de Cancérologie du Grand Montpellier, Montpellier, Languedoc-Roussillon, France
Clinique Victor Hugo Le Mans, Le Mans, Pays-de-la-Loire, France
Centre Leon Berard, Lyon CEDEX 08, Rhône-Alpes, France
CHD Vendee, La Roche-sur-Yon, Vendée, France
CHU de Bordeaux Hop St ANDRE, Bordeaux, , France
Christophe TOURNIGAND, Créteil, Île-de-France, France
Studienpraxis Urologie, Nürtingen, Baden-Württemberg, Germany
Universitaetsklinikum Tuebingen, Tübingen, Baden-Württemberg, Germany
Gesundheitszentrum Holzminden, Holzminden, Niedersachsen, Germany
Studienzentrum Bayenthal Urologische Partnerschaft Köln, Cologne, Nordrhein-Westfalen, Germany
Urologie Neandertal - Praxis Mettmann, Mettmann, Nordrhein-Westfalen, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus, Münster, Nordrhein-Westfalen, Germany
Private Practice - Dr. Stammel & Dr. Garcia, Wesel, Nordrhein-Westfalen, Germany
Private Practice - Dr. Ralf Eckert, Lutherstadt Eisleben, Sachsen-Anhalt, Germany
Private Practice - Dr. Silvio Szymula, Leipzig, Sachsen, Germany
Japanese Red Cross Nagoya Daini Hospital, Nagoya, Aichi, 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, Hyogo, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, 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
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Asan Medical Center, Songpagu, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Canisius-Wilhelmina Ziekenhuis, Nijmegen, Gelderland, Netherlands
Erasmus Medisch Centrum, Rotterdam, Zuid-Holland, Netherlands
St. Antonius Ziekenhuis, locatie Utrecht, Utrecht, , Netherlands
Ovidius Clinical Hospital OCH, Ovidiu, Constanța, Romania
Centrul de Oncologie "Sfântul Nectarie", Craiova, Dolj, Romania
Gral Medical Diagnostic Center, București, , Romania
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, Malaga, Málaga, Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Name: 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)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR