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:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 116 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 More Info
Contact
61407501095
Arun Azad
Principal Investigator
St Vincent's Hospital
Melbourne Victoria, 3065, Australia
Lanzhou university second hospital
Lanzhou Gansu, 73003, China More Info
Contact
19842852328
Li Yang
Principal Investigator
Sun Yat-sen University Cancer Center
Guangzhou Guangdong, 51006, China More Info
Contact
13922735659
FangJian Zhou
Principal Investigator
Yijishan Hospital of Wannan Medical College
Wuhu Hefei, 24100, China More Info
Contact
13955377989
Houbao Huang
Principal Investigator
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15008, China More Info
Contact
13603612355
Hui Chen
Principal Investigator
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Henan, 47100, China More Info
Contact
13721677921
Zhijun Li
Principal Investigator
Wu Han Tongji Hospital
Wuhan City Hubei, 43003, China More Info
Contact
13367255851
Shaogang Wang
Principal Investigator
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan Hubei, 43002, China More Info
Xiaoping Zhang
Principal Investigator
Hunan Cancer Hospital
Changsha Hunan, 41001, China More Info
Contact
13907110640
Weiqing Han
Principal Investigator
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing Jiangsu, 21000, China More Info
Contact
13605171690
Hongqian Guo
Principal Investigator
Nantong Tumor Hospital
Nantong Jiangsu, 22600, China More Info
Contact
15950868500
Xiaolin Wang
Principal Investigator
Wuxi People's Hospital
Wuxi Jiangsu, 21402, China More Info
Contact
13358112031
Zhuoqun Xu
Principal Investigator
The First Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China More Info
Contact
13607916789
Gongxian Wang
Principal Investigator
Jilin Province People's Hospital
Changchun Jilin, 13002, China More Info
Yong Wang
Principal Investigator
Yantai Yuhuangding hospital
Yantai Shandong, 26400, China More Info
Contact
18953568877
Jitao Wu
Principal Investigator
HuaShan Hospital Affiliated To Fudan University
Shanghai Shanghai, 20040, China More Info
Contact
18121186785
Haowen Jiang
Principal Investigator
Nanchong Central Hospital
Nanchong Sichuan, 63700, China More Info
Contact
0817-2606822
Fan Jun
Principal Investigator
The Second Hospital of Tianjin Medical University
Tianjin Tianjin, 30021, China More Info
Contact
18630955984
Haitao Wang
Principal Investigator
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, , China More Info
Contact
13803000688
Xin Yao
Principal Investigator
Xinjiang Medical University Cancer Hospital
Urumqi Xinjiang, 83000, China More Info
Contact
13609982787
Peng Chen
Principal Investigator
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou Zhejiang, 31000, China More Info
Contact
13858122288
Baiye Jin
Principal Investigator
Zhejiang Provincial People's Hospital
Hangzhou Zhejiang, 31001, China More Info
Contact
13705711671
Dahong Zhang
Principal Investigator
Ningbo First Hospital
Ningbo Zhejiang, 31501, China More Info
Ma Qi
Principal Investigator
People's Hospital of Hunan Province
Changsha , 41000, China More Info
Contact
15973121068
Yuanwei Li
Principal Investigator
Second affiliated hospital of anhui medical university
He Fei , 23000, China More Info
Contact
0551-65997146
Dexin Yu
Principal Investigator
Fudan University Shanghai Cancer Center
Shanghai , 20003, China More Info
Contact
13701663571
Dingwei Ye
Principal Investigator
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'An , 71006, China More Info
Contact
15991752560
Lei Li
Principal Investigator
Finsen Institute
Copenhagen , 2100, Denmark
Næstved Sygehus
Næstved , 4700, Denmark
Centre Hospitalier de la Côte Basque
Bayonne Pyrénées-Atlantiques, 64109, France More Info
Contact
0033559443762
Louis François
Principal Investigator
CHU de Bordeaux Hop St ANDRE
Bordeaux , 33075, France More Info
Contact
0033556794708
Marine Gross-Goupil
Principal Investigator
CHU Henri Mondor
Creteil Cedex , 94010, France More Info
Contact
0033149812576
Christophe Tournigand
Principal Investigator
CHD Vendee
La Roche Sur Yon , 85025, France More Info
Contact
0033251446173
Frank Priou
Principal Investigator
Clinique Victor Hugo - Centre Jean Bernard
Le Mans , 72000, France More Info
Contact
0033243391300
Amandine Ruffier
Principal Investigator
Centre Leon Berard
Lyon Cedex 08 , 69373, France More Info
Contact
0033478782643
Aude Flechon
Principal Investigator
Centre de Cancérologie du Grand Montpellier
Montpellier , 34070, France
Studienpraxis Urologie
Nürtingen Baden-Württemberg, 72622, Germany
Gesundheitszentrum Holzminden
Holzminden Niedersachsen, 37603, Germany More Info
Manfred Binder
Principal Investigator
Universitätsklinikum Münster
Münster Nordrhein-Westfalen, 48149, Germany
Urologische Gemeinschaftspraxis Wesel
Wesel North Rhine-Westphalia, 46483, Germany More Info
Miguel José Garcia Schürmann
Principal Investigator
Urologische Arztpraxis in Eisleben - Dr. med. Ralf Eckert
Lutherstadt Eisleben Saxony-Anhalt, 06295, Germany More Info
Ralf Eckert
Principal Investigator
Urologie am Nordplatz - Urologische Facharztpraxis Dr. med. Silvio Szymula
Leipzig Saxony, 04105, Germany More Info
Silvio Szymula
Principal Investigator
Urologie Bayenthal in Köln
Köln , 50968, Germany More Info
Contact
0049221362025
Jörg Klier
Principal Investigator
Urologie Neandertal - Praxis Mettmann
Mettmann , 40822, Germany
Universitätsklinikum Tübingen
Tübingen , 72076, Germany
Red Cross Aichi Hospital
Nagoya Aichi, 466-0, Japan More Info
Contact
81120023812
Toshinori Nishikimi
Principal Investigator
Hirosaki University Hospital
Hirosaki Aomori, 036-8, Japan More Info
Contact
81120023812
Naoki Fujita
Principal Investigator
Toho University Sakura Medical Center
Sakura Chiba, 285-8, Japan More Info
Contact
81120023812
Hiroyoshi Suzuki
Principal Investigator
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan More Info
Contact
81120023812
Ryuji Matsumoto
Principal Investigator
Kobe City Medical Center General Hospital
Kobe Hyogo, 650-0, Japan More Info
Contact
81120023812
Mutsushi Kawakita
Principal Investigator
Kanazawa University Hospital
Kanazawa Ishikawa, 920-8, Japan More Info
Contact
81120023812
Atsushi Mizokami
Principal Investigator
Yokohama City University Medical Center
Yokohama Kanagawa, 232-0, Japan More Info
Contact
81120023812
Hiroji Uemura
Principal Investigator
Saitama Prefectural Cancer Center
Ina-machi Saitama, 362-0, Japan More Info
Contact
81120023812
Yukio Kageyama
Principal Investigator
Hamamatsu University School of Medicine University Hospital
Hamamatsu Shizuoka, 431-3, Japan More Info
Contact
81120023812
Takayuki Sugiyama
Principal Investigator
Showa University Hospital
Shinagawa Tokyo, 142-8, Japan More Info
Contact
81120023812
Takashi Fukagai
Principal Investigator
Gifu University Hospital
Gifu , 501-1, Japan More Info
Contact
81120023812
Keita Nakane
Principal Investigator
National Hospital Organization Kumamoto Medical Center
Kumamoto , 860-0, Japan More Info
Contact
81120023812
Hiroaki Kikukawa
Principal Investigator
Osaka International Cancer Institute
Osaka , 541-8, Japan More Info
Contact
81120023812
Kazuo Nishimura
Principal Investigator
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
Gral Medical SRL
Bucuresti București, 03142, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova Dolj, 20054, Romania More Info
Contact
0040351401336
Michael Schenker
Principal Investigator
Radiology Therapeutic Center
Otopeni Ilfov, 07510, Romania More Info
Contact
0040372744344
Elena Ciubotaru
Principal Investigator
Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanta , 90059, Romania
Hospital Universitario Virgen de la Victoria
Malaga Andalucia, 29010, Spain More Info
Contact
0034951032508
Alvaro Montesa Pino
Principal Investigator
Institut Catala d'Oncologia
L'Hospitalet de Llobregat Barcelona, 08907, Spain More Info
Contact
0034932607744
Jose Maria Maria Piulats Rodriguez
Principal Investigator
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain More Info
Contact
0034934893846
Joan Carles Galcerán
Principal Investigator
Hospital Clinic I Provincial
Barcelona , 08036, Spain More Info
Contact
0034934536561
Begoña Mellado
Principal Investigator
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain More Info
Contact
0034914269070
Jose Angel Angel Arranz Arija
Principal Investigator
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain More Info
Contact
0034913368263
Teresa Alonso Gordoa
Principal Investigator
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
Contact
0034913908000
Guillermo de Velasco Oria de Rueda
Principal Investigator
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:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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