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 98 Locations for this study
Phoenix Arizona, 85004, United States
Phoenix Arizona, 85054, United States
Tucson Arizona, 85719, United States
Jonesboro Arkansas, 72401, United States
Bakersfield California, 93309, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Los Angeles California, 90024, 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
Atlanta Georgia, 30342, United States
Fort Wayne Indiana, 46804, United States
Columbia Maryland, 21044, United States
Boston Massachusetts, 02114, United States
Minneapolis Minnesota, 55455, United States
Las Vegas Nevada, 89119, United States
Albany New York, 12206, United States
Syracuse New York, 13210, United States
Nashville Tennessee, 37203, United States
Temple Texas, 76508, United States
The Woodlands Texas, 77380, United States
The Woodlands Texas, 77380, United States
The Woodlands Texas, 77380, United States
The Woodlands Texas, 77380, United States
The Woodlands Texas, 77380, United States
The Woodlands Texas, 77380, United States
The Woodlands Texas, 77380, United States
Salt Lake City Utah, 84112, United States
Burlington Vermont, 05405, United States
Camperdown New South Wales, 2050, Australia
Kogarah New South Wales, 2228, Australia
Macquarie University New South Wales, 2109, Australia
Randwick New South Wales, 2031, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3065, Australia
Hefei Anhui, 23000, China
Wuhu Anhui, 24100, China
Lanzhou Gansu, 73003, China
Guangzhou Guangdong, 51006, China
Harbin Heilongjiang, 15008, China
Luoyang Henan, 47100, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43003, China
ChangSha Hunan, 41000, China
Changsha Hunan, 41001, China
Nantong Jiangsu, 22636, China
Wuxi Jiangsu, 21402, China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13002, China
Xi'an Shaanxi, 71006, China
Yantai Shandong, 26409, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20004, China
Nanchong Sichuan, 63700, China
Tianjin Tianjin, 30006, China
Tianjin Tianjin, 30021, China
Urumqi Xinjiang, 83000, China
Hangzhou Zhejiang, 31000, China
Ningbo Zhejiang, 31501, China
Copenhagen Hovedstaden, 2100, Denmark
Næstved Sjælland, 4700, Denmark
Montpellier Languedoc-Roussillon, 34070, France
Le Mans Pays-de-la-Loire, 72000, France
Lyon CEDEX 08 Rhône-Alpes, 69373, France
La Roche-sur-Yon Vendée, 85000, France
Bordeaux , 33075, France
Créteil Île-de-France, , 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
Münster Nordrhein-Westfalen, 48149, 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
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
Osaka , 541-8, Japan
Seoul Seoul-teukbyeolsi [Seoul], 3080, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 3722, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 6351, Korea, Republic of
Songpagu Seoul-teukbyeolsi [Seoul], 5505, Korea, Republic of
Nijmegen Gelderland, 6532 , Netherlands
Utrecht , 3543 , Netherlands
Ovidiu Constanța, 90590, Romania
Craiova Dolj, 20054, Romania
București , 31422, Romania
Barcelona Barcelona [Barcelona], 8035, Spain
Hospitalet Barcelona [Barcelona], 8907, Spain
Barcelona Catalunya [Cataluña], 8036, Spain
Madrid Madrid, Comunidad De, 28041, Spain
Malaga Málaga, 29010, Spain
Madrid , 28009, Spain
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