Prostate Cancer Clinical Trial
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
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 Criteria
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).
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There are 69 Locations for this study
Tucson Arizona, 85719, United States
Jonesboro Arkansas, 72401, United States
Bakersfield California, 93309, United States
Los Angeles California, 90095, United States
Monterey California, 93940, United States
Santa Barbara California, 93105, United States
Lone Tree Colorado, 80124, United States
Hollywood Florida, 33024, United States
Palm Bay Florida, 32909, United States
Fort Wayne Indiana, 46804, United States
Columbia Maryland, 21044, United States
Minneapolis Minnesota, 55455, United States
Kansas City Missouri, 63142, United States
Syracuse New York, 13210, United States
Tulsa Oklahoma, 74146, United States
Tigard Oregon, 97223, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Longview Texas, 75601, United States
Temple Texas, 76508, United States
The Woodlands Texas, 77380, United States
Waco Texas, 76712, United States
Camperdown New South Wales, 2050, Australia
Kogarah New South Wales, 2228, Australia
Lanzhou Gansu, 73003, China
Luoyang Henan, 47100, China
Wuhan Hubei, 43002, China
ChangSha Hunan, 41000, China
Changsha Hunan, 41001, China
Wuxi Jiangsu, 21402, China
Yantai Shandong, 26409, China
Shanghai Shanghai, 20004, China
Nanchong Sichuan, 63700, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Copenhagen Hovedstaden, 2100, Denmark
Montpellier Languedoc-Roussillon, 34070, France
Lyon CEDEX 08 Rhône-Alpes, 69373, France
Bordeaux , 33075, France
Nürtingen Baden-Württemberg, 72622, Germany
Tübingen Baden-Württemberg, 72076, Germany
Holzminden Niedersachsen, 37603, Germany
Cologne Nordrhein-Westfalen, 50968, Germany
Mettmann Nordrhein-Westfalen, 40822, Germany
Wesel Nordrhein-Westfalen, 46483, Germany
Lutherstadt Eisleben Sachsen-Anhalt, 06295, Germany
Leipzig Sachsen, 4105, Germany
Nagoya Aichi, 466-8, Japan
Hirosaki Aomori, 036-8, Japan
Sakura Chiba, 285-0, Japan
Sapporo Hokkaido, 060-8, Japan
Kobe Hyogo, 650-0, Japan
Kanazawa Ishikawa, 920-8, Japan
Yokohama Kanagawa, 232-0, Japan
Ina-machi Saitama, 362-0, Japan
Hamamatsu Shizuoka, 431-3, Japan
Shinagawa Tokyo, 142-8, Japan
Gifu , 501-1, Japan
Kumamoto , 860-0, Japan
Osaka , 541-8, Japan
Seoul Seoul-teukbyeolsi [Seoul], 6351, Korea, Republic of
Nijmegen Gelderland, 6532 , Netherlands
Rotterdam Zuid-Holland, 3015 , Netherlands
Malaga Málaga, 29010, Spain
Plymouth Devon, Pl6 8, United Kingdom
London Hammersmith And Fulham, W6 8R, United Kingdom
London London, City Of, NW1 2, United Kingdom
Northampton Northamptonshire, NN1 5, United Kingdom
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