A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer
Who is this study for? Adult patients with metastatic castration-resistant prostate cancer
What treatments are being studied? Abiraterone Acetate+Prednisone
Status: Active_not_recruiting
Location: See all (112) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
St. Bernards Medical Center
Jonesboro
Arizona
Mayo Clinic in Arizona - Phoenix
Phoenix
St. Joseph's Hospital and Medical Center
Phoenix
The University of Arizona Cancer Center - North Campus
Tucson
California
CBCC Global Research, Inc.
Bakersfield
Providence St. Jude Medical Center
Fullerton
Moores Cancer Center
La Jolla
TRIO-US (Translational Research in Oncology-US)
Los Angeles
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles
Pacific Cancer Care
Monterey
Sansum Clinic_Kendle
Santa Barbara
Colorado
Rocky Mountain Cancer Center
Lone Tree
Florida
Millennium Oncology - Hollywood
Hollywood
Georgia
Northside Hospital
Atlanta
Indiana
Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
Fort Wayne
Massachusetts
Massachusetts General Hospital
Boston
Minnesota
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
Albany
Associated Medical Professionals - Urology
Syracuse
Tennessee
Research Medical Center
Nashville
Texas
Baylor Scott & White Medical Center - Temple
Temple
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
The Woodlands
Northwest Cancer Specialists PC
The Woodlands
Sansum Clinic_Kendle
The Woodlands
Texas Oncology - Longview Cancer Center
The Woodlands
Texas Oncology Cancer Care and Research Center
The Woodlands
Texas Oncology Fort Worth
The Woodlands
Texas Oncology-Memorial City
The Woodlands
US Oncology
The Woodlands
USO-Cancer Care Center of Brevard, Inc.
The Woodlands
Utah
Huntsman Cancer Institute
Salt Lake City
Vermont
The University of Vermont Medical Center Inc.
Burlington
Other Locations
Australia
Chris O'Brien Lifehouse
Camperdown
Southside Cancer Care Centre
Kogarah
Macquarie University
Macquarie University
Peter MacCallum Cancer Centre
Melbourne
St Vincent's Hospital
Melbourne
Prince of Wales Hospital
Randwick
China
Jilin Province People's Hospital
Changchun
Hunan Cancer Hospital
Changsha
Hunan Provincial People's Hospital
Changsha
Sun Yat-Sen University Cancer Centre
Guangzhou
The First Affiliated Hospital, Zhejiang University
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Second Affiliated hospital of Anhui Medical University
Hefei
Lanzhou university second hospital
Lanzhou
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang
The First Affiliated Hospital of Nanchang University
Nanchang
Nanchong Central Hospital
Nanchong
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing
Nanjing
Nantong Tumor Hospital
Nantong
Ningbo First Hospital
Ningbo
Fudan University Shanghai Cancer Center
Shanghai
Huashan Hospital Affiliated Fudan University
Shanghai
The Second Hospital of Tianjin Medical University
Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Xinjiang Medical University Cancer Hospital - Urumqi
Urumqi
Tongji Hospital Tongji Medical,Science & Technology
Wuhan
Wuhan Union Hospital
Wuhan
Wannan Medical College Yijishan Hospital
Wuhu
Wuxi People's Hospital
Wuxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Yantai Yuhuangding Hospital
Yantai
Denmark
Rigshospitalet
Copenhagen
Næstved Sygehus
Næstved
France
CHU de Bordeaux Hop St ANDRE
Bordeaux
Henri Mondor Hospital
Créteil
CHD Vendee
La Roche-sur-yon
Clinique Victor Hugo Le Mans
Le Mans
Centre Leon Berard
Lyon Cedex 08
Centre de Cancérologie du Grand Montpellier
Montpellier
Germany
Studienzentrum Bayenthal Urologische Partnerschaft Köln
Cologne
Gesundheitszentrum Holzminden
Holzminden
Private Practice - Dr. Silvio Szymula
Leipzig
Private Practice - Dr. Ralf Eckert
Lutherstadt Eisleben
Urologie Neandertal - Praxis Mettmann
Mettmann
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster
Studienpraxis Urologie
Nürtingen
Universitaetsklinikum Tuebingen
Tübingen
Private Practice - Dr. Stammel & Dr. Garcia
Wesel
Japan
Gifu University Hospital
Gifu
Hamamatsu University Hospital
Hamamatsu
Hirosaki University Hospital
Hirosaki
Saitama Prefectural Cancer Center
Ina-machi
Kanazawa University Hospital
Kanazawa
Kobe City Medical Center General Hospital
Kobe
National Hospital Organization Kumamoto Medical Center
Kumamoto
Japanese Red Cross Nagoya Daini Hospital
Nagoya
Osaka International Cancer Institute
Osaka
Toho University Sakura Medical Center
Sakura
Hokkaido University Hospital
Sapporo
Showa University Hospital
Shinagawa
Yokohama City University Medical Center
Yokohama
Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen
Erasmus Medisch Centrum
Rotterdam
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht
Republic of Korea
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Asan Medical Center
Songpagu
Romania
Gral Medical Diagnostic Center
București
Centrul de Oncologie Sfântul Nectarie
Craiova
Ovidius Clinical Hospital OCH
Ovidiu
Spain
Hospital Clínic de Barcelona
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Virgen de la Victoria
Malaga
Time Frame
Start Date: 2018-11-26
Completion Date: 2026-06
Participants
Target number of participants: 393
Treatments
Experimental: Abemaciclib
Participants received 200 milligrams (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
Placebo_comparator: Placebo
Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
Authors
Louis François, Matthew Smith, David Wise, Robert Jotte, Julian Reed Davis, Alan Bryce, Isaac Levy, Andrew Kraft, Christopher Pieczonka, Christopher H Chay, Alexandra Drakaki, Brian D Vicuna, David R Shaffer, Rana McKay, Lijo John, Sherronda M Henderson, Carl Chakmakjian, Daniel P. Petrylak, David Eduardo Kanamori, Ahad A Sadiq, Laura Stampleman, Arpit Rao, Daniel Landau, Luke Nordquist, Jue Wang, Mark R Olsen, Neeraj Agarwal, Gurjyot K Doshi, Sonia Seng, Stephen L Richey, Robert F Hunter-Mellado, Martin Bögemann, Ursula McGovern, Frank Priou, Arnulf Stenzl, Tilman Todenhöfer, Susan Feyerabend, Christophe Tournigand, Mario Uccello, Aude Flechon, Jörg Klier, Marine Gross-Goupil, Peter Sankey, Paul M Swanson, Sanjay Sharma, Antony Charles, Kevin Courtney, Mazen Khalil, Steven Ades, John M Wallmark, Zhijun Li, Paul De Souza, Weiqing Han, Elizabeth Hovey, JOAN CARLES GALCERÁN, Gongxian Wang, Zhuoqun Xu, Teresa Alonso, Maartje Los, Dahong Zhang, Xin Yao, Bhumsuk Keam, Howard Gurney, FangJian Zhou, Jae Lyun Lee, Amandine Ruffier, Toshinori Nishikimi, Mutsushi Kawakita, Atsushi Mizokami, Keita Nakane, Hongqian Guo, Haitao Wang, Kazuo Nishimura, Naoki Fujita, ANTHONY DOWLING, Yukio Kageyama, Naveed Sarwar, Sang Joon Shin, Begoña Mellado, Ryuji Matsumoto, Hiroji Uemura, Se Hoon Park, Takashi Fukagai, Dingwei Ye, Takayuki Sugiyama, Gedske Daugaard, Houbao Huang, Haowen Jiang, Arun Azad, Ronald de Wit, Lisa Horvath, Jitao Wu, Hiroyoshi Suzuki, Dexin Yu, Michael Schenker, Baiye Jin
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company