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.

View Eligibility Criteria

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).

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

350

Study ID:

NCT03706365

Recruitment Status:

Active, not recruiting

Sponsor:

Eli Lilly and Company

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There are 104 Locations for this study

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St. Joseph's Hospital and Medical Center
Phoenix Arizona, 85004, United States
Mayo Clinic in Arizona - Phoenix
Phoenix Arizona, 85054, United States
The University of Arizona Cancer Center - North Campus
Tucson Arizona, 85719, United States
St. Bernards Medical Center
Jonesboro Arkansas, 72401, United States
CBCC Global Research, Inc.
Bakersfield California, 93309, United States
St. Jude Medical Center
Fullerton California, 92835, United States
Moores Cancer Center
La Jolla California, 92093, United States
TRIO-US (Translational Research in Oncology-US)
Los Angeles California, 90024, United States
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles California, 90095, United States
Pacific Cancer Care
Monterey California, 93940, United States
Sansum Clinic_Kendle
Santa Barbara California, 93105, United States
Rocky Mountain Cancer Center
Lone Tree Colorado, 80124, United States
Millennium Oncology - Hollywood
Hollywood Florida, 33024, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
Fort Wayne Indiana, 46804, United States
Maryland Oncology Hematology - Columbia
Columbia Maryland, 21044, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis Minnesota, 55455, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89119, United States
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
Albany New York, 12206, United States
Associated Medical Professionals - Urology
Syracuse New York, 13210, United States
Research Medical Center
Nashville Tennessee, 37203, United States
Baylor Scott & White Medical Center - Temple
Temple Texas, 76508, United States
Northwest Cancer Specialists PC
The Woodlands Texas, 77380, United States
Texas Oncology - Longview Cancer Center
The Woodlands Texas, 77380, United States
Texas Oncology Cancer Care and Research Center
The Woodlands Texas, 77380, United States
Texas Oncology Fort Worth
The Woodlands Texas, 77380, United States
Texas Oncology-Memorial City
The Woodlands Texas, 77380, United States
US Oncology
The Woodlands Texas, 77380, United States
USO-Cancer Care Center of Brevard, Inc.
The Woodlands Texas, 77380, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
The University of Vermont Medical Center Inc.
Burlington Vermont, 05405, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Southside Cancer Care Centre
Kogarah New South Wales, 2228, Australia
Macquarie University
Macquarie University New South Wales, 2109, Australia
Prince of Wales Hospital
Randwick New South Wales, 2031, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
St Vincent's Hospital
Melbourne Victoria, 3065, Australia
Second Affiliated hospital of Anhui Medical University
Hefei Anhui, 23000, China
Wannan Medical College Yijishan Hospital
Wuhu Anhui, 24100, China
Lanzhou university second hospital
Lanzhou Gansu, 73003, China
Sun Yat-Sen University Cancer Centre
Guangzhou Guangdong, 51006, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15008, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Henan, 47100, China
Wuhan Union Hospital
Wuhan Hubei, 43002, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan Hubei, 43003, China
Hunan Provincial People's Hospital
ChangSha Hunan, 41000, China
Hunan Cancer Hospital
Changsha Hunan, 41001, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing Jiangsu, 21000, China
Nantong Tumor Hospital
Nantong Jiangsu, 22636, China
Wuxi People's Hospital
Wuxi Jiangsu, 21402, China
The First Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
Jilin Province People's Hospital
Changchun Jilin, 13002, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an Shaanxi, 71006, China
Yantai Yuhuangding Hospital
Yantai Shandong, 26409, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20003, China
Huashan Hospital Affiliated Fudan University
Shanghai Shanghai, 20004, China
Nanchong Central Hospital
Nanchong Sichuan, 63700, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China
The Second Hospital of Tianjin Medical University
Tianjin Tianjin, 30021, China
Xinjiang Medical University Cancer Hospital - Urumqi
Urumqi Xinjiang, 83000, China
The First Affiliated Hospital, Zhejiang University
Hangzhou Zhejiang, 31000, China
Zhejiang Provincial People's Hospital
Hangzhou Zhejiang, 31001, China
Ningbo First Hospital
Ningbo Zhejiang, 31501, China
Rigshospitalet
Copenhagen Hovedstaden, 2100, Denmark
Næstved Sygehus
Næstved Sjælland, 4700, Denmark
Centre de Cancérologie du Grand Montpellier
Montpellier Languedoc-Roussillon, 34070, France
Clinique Victor Hugo Le Mans
Le Mans Pays-de-la-Loire, 72000, France
Centre Leon Berard
Lyon CEDEX 08 Rhône-Alpes, 69373, France
CHD Vendee
La Roche-sur-Yon Vendée, 85000, France
CHU de Bordeaux Hop St ANDRE
Bordeaux , 33075, France
Christophe TOURNIGAND
Créteil Île-de-France, , France
Studienpraxis Urologie
Nürtingen Baden-Württemberg, 72622, Germany
Universitaetsklinikum Tuebingen
Tübingen Baden-Württemberg, 72076, Germany
Gesundheitszentrum Holzminden
Holzminden Niedersachsen, 37603, Germany
Studienzentrum Bayenthal Urologische Partnerschaft Köln
Cologne Nordrhein-Westfalen, 50968, Germany
Urologie Neandertal - Praxis Mettmann
Mettmann Nordrhein-Westfalen, 40822, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster Nordrhein-Westfalen, 48149, Germany
Private Practice - Dr. Stammel & Dr. Garcia
Wesel Nordrhein-Westfalen, 46483, Germany
Private Practice - Dr. Ralf Eckert
Lutherstadt Eisleben Sachsen-Anhalt, 06295, Germany
Private Practice - Dr. Silvio Szymula
Leipzig Sachsen, 4105, Germany
Japanese Red Cross Nagoya Daini Hospital
Nagoya Aichi, 466-8, Japan
Hirosaki University Hospital
Hirosaki Aomori, 036-8, Japan
Toho University Sakura Medical Center
Sakura Chiba, 285-0, Japan
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan
Kobe City Medical Center General Hospital
Kobe Hyogo, 650-0, Japan
Kanazawa University Hospital
Kanazawa Ishikawa, 920-8, Japan
Yokohama City University Medical Center
Yokohama Kanagawa, 232-0, Japan
Saitama Prefectural Cancer Center
Ina-machi Saitama, 362-0, Japan
Hamamatsu University Hospital
Hamamatsu Shizuoka, 431-3, Japan
Showa University Hospital
Shinagawa Tokyo, 142-8, Japan
Gifu University Hospital
Gifu , 501-1, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto , 860-0, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Seoul National University Hospital
Seoul Seoul-teukbyeolsi [Seoul], 3080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul Seoul-teukbyeolsi [Seoul], 3722, Korea, Republic of
Samsung Medical Center
Seoul Seoul-teukbyeolsi [Seoul], 6351, Korea, Republic of
Asan Medical Center
Songpagu Seoul-teukbyeolsi [Seoul], 5505, Korea, Republic of
Canisius-Wilhelmina Ziekenhuis
Nijmegen Gelderland, 6532 , Netherlands
Erasmus Medisch Centrum
Rotterdam Zuid-Holland, 3015 , Netherlands
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht , 3543 , Netherlands
Ovidius Clinical Hospital OCH
Ovidiu Constanța, 90590, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova Dolj, 20054, Romania
Gral Medical Diagnostic Center
București , 31422, Romania
Hospital Universitari Vall d'Hebron
Barcelona Barcelona [Barcelona], 8035, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet Barcelona [Barcelona], 8907, Spain
Hospital Clínic de Barcelona
Barcelona Catalunya [Cataluña], 8036, Spain
Hospital Universitario Ramón y Cajal
Madrid Madrid, Comunidad De, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid Madrid, Comunidad De, 28041, Spain
Hospital Universitario Virgen de la Victoria
Malaga Málaga, 29010, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28009, Spain

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

350

Study ID:

NCT03706365

Recruitment Status:

Active, not recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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