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 69 Locations for this study

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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
TRIO-US (Translational Research in Oncology-US)
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
USO-Cancer Care Center of Brevard, Inc.
Palm Bay Florida, 32909, 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
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis Minnesota, 55455, United States
Research Medical Center
Kansas City Missouri, 63142, United States
Associated Medical Professionals - Urology
Syracuse New York, 13210, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa Oklahoma, 74146, United States
Northwest Cancer Specialists PC
Tigard Oregon, 97223, United States
Texas Oncology Fort Worth
Fort Worth Texas, 76104, United States
Texas Oncology-Memorial City
Houston Texas, 77024, United States
Texas Oncology - Longview Cancer Center
Longview Texas, 75601, United States
Baylor Scott & White Medical Center - Temple
Temple Texas, 76508, United States
US Oncology
The Woodlands Texas, 77380, United States
Texas Oncology Cancer Care and Research Center
Waco Texas, 76712, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Southside Cancer Care Centre
Kogarah New South Wales, 2228, Australia
Lanzhou university second hospital
Lanzhou Gansu, 73003, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Henan, 47100, China
Wuhan Union Hospital
Wuhan Hubei, 43002, China
Hunan Provincial People's Hospital
ChangSha Hunan, 41000, China
Hunan Cancer Hospital
Changsha Hunan, 41001, China
Wuxi People's Hospital
Wuxi Jiangsu, 21402, China
Yantai Yuhuangding Hospital
Yantai Shandong, 26409, 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 First Affiliated Hospital, Zhejiang University
Hangzhou Zhejiang, 31000, China
Zhejiang Provincial People's Hospital
Hangzhou Zhejiang, 31001, China
Rigshospitalet
Copenhagen Hovedstaden, 2100, Denmark
Centre de Cancérologie du Grand Montpellier
Montpellier Languedoc-Roussillon, 34070, France
Centre Leon Berard
Lyon CEDEX 08 Rhône-Alpes, 69373, France
CHU de Bordeaux Hop St ANDRE
Bordeaux , 33075, 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
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
Samsung Medical Center
Seoul Seoul-teukbyeolsi [Seoul], 6351, Korea, Republic of
Canisius-Wilhelmina Ziekenhuis
Nijmegen Gelderland, 6532 , Netherlands
Erasmus Medisch Centrum
Rotterdam Zuid-Holland, 3015 , Netherlands
Hospital Universitario Virgen de la Victoria
Malaga Málaga, 29010, Spain
Derriford Hospital
Plymouth Devon, Pl6 8, United Kingdom
Charing Cross Hospital
London Hammersmith And Fulham, W6 8R, United Kingdom
University College London Hospital
London London, City Of, NW1 2, United Kingdom
Northampton General Hospital NHS Trust
Northampton Northamptonshire, NN1 5, United Kingdom

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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