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

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 115 Locations for this study

See Locations Near You

University of Arizona Cancer Center
Phoenix Arizona, 85004, United States
Mayo Clinic Hospital
Phoenix Arizona, 85054, United States
The University of Arizona Cancer Center
Tucson Arizona, 85719, United States
St. Bernards Medical Center
Jonesboro Arkansas, 72401, United States
CBCC Global Research, Inc.
Bakersfield California, 93309, United States
St. Joseph Heritage Healthcare
Fullerton California, 92935, United States
University of California - San Diego
La Jolla California, 92037, United States
UCLA Medical Center
Los Angeles California, 90024, 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
Solvang California, 93463, United States
Rocky Mountain Cancer Center
Lone Tree Colorado, 80124, United States
Millennium Oncology
Hollywood Florida, 33024, United States
Cancer Care Center of Brevard
Palm Bay Florida, 32909, United States
Northside Hospital Cancer Institute
Marietta Georgia, 30060, United States
Fort Wayne Medical Oncology & Hematology, Inc.
Fort Wayne Indiana, 46804, United States
Maryland Oncology Hematology, P.A.
Silver Spring Maryland, 20904, United States
Massachusetts General Hospital
Boston Massachusetts, 02115, United States
University of Minnesota Hospital
Minneapolis Minnesota, 55455, United States
Research Medical Center
Kansas City Missouri, 63142, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
New York Oncology Hematology, P.C
Albany New York, 12208, United States
Associated Medical Professionals - Urology
Syracuse New York, 13210, 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
University of Utah School of Medicine
Salt Lake City Utah, 84132, United States
University of Vermont Medical Center
Burlington Vermont, 05401, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Southside Cancer Care Centre
Kogarah New South Wales, 2228, Australia
Macquarie University Hospital
Macquarie Park 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
Lanzhou university second hospital
Lanzhou Gansu, 73003, China
Sun Yat-sen University Cancer Center
Guangzhou Guangdong, 51006, China
Yijishan Hospital of Wannan Medical College
Wuhu Hefei, 24100, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15008, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Henan, 47100, China
Wu Han Tongji Hospital
Wuhan City Hubei, 43003, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan Hubei, 43002, 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, 22600, 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
Yantai Yuhuangding hospital
Yantai Shandong, 26400, China
HuaShan Hospital Affiliated To Fudan University
Shanghai Shanghai, 20040, China
Nanchong Central Hospital
Nanchong Sichuan, 63700, China
The Second Hospital of Tianjin Medical University
Tianjin Tianjin, 30021, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, , China
Xinjiang Medical University Cancer Hospital
Urumqi Xinjiang, 83000, China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou Zhejiang, 31000, China
Zhejiang Provincial People's Hospital
Hangzhou Zhejiang, 31001, China
Ningbo First Hospital
Ningbo Zhejiang, 31501, China
People's Hospital of Hunan Province
Changsha , 41000, China
Second affiliated hospital of anhui medical university
He Fei , 23000, China
Fudan University Shanghai Cancer Center
Shanghai , 20003, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'An , 71006, China
Finsen Institute
Copenhagen , 2100, Denmark
Næstved Sygehus
Næstved , 4700, Denmark
CHU de Bordeaux Hop St ANDRE
Bordeaux , 33075, France
CHU Henri Mondor
Creteil Cedex , 94010, France
CHD Vendee
La Roche Sur Yon , 85025, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans , 72000, France
Centre Leon Berard
Lyon Cedex 08 , 69373, France
Centre de Cancérologie du Grand Montpellier
Montpellier , 34070, France
Studienpraxis Urologie
Nürtingen Baden-Württemberg, 72622, Germany
Universitaetsklinikum Tuebingen
Tübingen Baden-Württemberg, 72076, Germany
Gesundheitszentrum Holzminden
Holzminden Niedersachsen, 37603, Germany
Universitätsklinikum Münster
Münster Nordrhein-Westfalen, 48149, Germany
Private Practice - Dr. Stammel & Dr. Garcia
Wesel Nordrhein-Westfalen, 46483, Germany
Urologische Arztpraxis in Eisleben - Dr. med. Ralf Eckert
Lutherstadt Eisleben Saxony-Anhalt, 06295, Germany
Urologie am Nordplatz - Urologische Facharztpraxis Dr. med. Silvio Szymula
Leipzig Saxony, 04105, Germany
Urologie Bayenthal in Köln
Köln , 50968, Germany
Urologie Neandertal - Praxis Mettmann
Mettmann , 40822, Germany
Red Cross Aichi Hospital
Nagoya Aichi, 466-0, Japan
Hirosaki University Hospital
Hirosaki Aomori, 036-8, Japan
Toho University Sakura Medical Center
Sakura Chiba, 285-8, 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, Korea, 03080, Korea, Republic of
Asan Medical Center
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of
Samsung Medical Center
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Canisius-Wilhelmina Ziekenhuis
Nijmegen Gelderland, 6532 , Netherlands
Erasmus Medisch Centrum
Rotterdam South Holland, 3015 , Netherlands
St. Antonius Ziekenhuis, locatie Nieuwegein
Utrecht , 3543 , Netherlands
Centrul de Oncologie "Sfântul Nectarie"
Craiova Dolj, 20054, Romania
Radiology Therapeutic Center
Otopeni Ilfov, 07510, Romania
Gral Medical SRL
București , 03142, Romania
Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanta , 90059, Romania
'Hospital Virgen de la Victoria
Malaga Andalucia, 29010, Spain
Institut Catala d'Oncologia
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic I Provincial
Barcelona , 08036, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Derriford Hospital
Plymouth Devon, PL6 8, United Kingdom
University College Hospital - London
London Greater London, NW1 2, United Kingdom
Charing Cross Hospital
London Hammersmith And Fulham, W6 8R, United Kingdom
Northampton General Hospital NHS Trust
Northampton , 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?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.