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Активно (без набиране) Фаза 2/3 NCT03706365

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

Фаза 2/3 – комбинирано изпитване
Заболявания: Prostate Cancer

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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).
Интервенции
Abemaciclib
DRUG
Placebo
DRUG
Abiraterone acetate
DRUG
Prednisone
DRUG
Места на провеждане 112
Австралия (6)
Chris O'Brien Lifehouse
Camperdown , New South Wales
Southside Cancer Care Centre
Kogarah , New South Wales
Macquarie University
Macquarie University , New South Wales
Peter MacCallum Cancer Centre
Melbourne , Victoria
St Vincent's Hospital
Melbourne , Victoria
Prince of Wales Hospital
Randwick , New South Wales
Китай (26)
Jilin Province People's Hospital
Changchun , Jilin
Hunan Provincial People's Hospital
Changsha , Hunan
Hunan Cancer Hospital
Changsha , Hunan
Sun Yat-Sen University Cancer Centre
Guangzhou , Guangdong
The First Affiliated Hospital, Zhejiang University
Hangzhou , Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou , Zhejiang
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
Second Affiliated hospital of Anhui Medical University
Hefei , Anhui
Lanzhou university second hospital
Lanzhou , Gansu
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang , Henan
The First Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Nanchong Central Hospital
Nanchong , Sichuan
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing
Nanjing , Jiangsu
Nantong Tumor Hospital
Nantong , Jiangsu
Ningbo First Hospital
Ningbo , Zhejiang
Fudan University Shanghai Cancer Center
Shanghai , Shanghai Municipality
Huashan Hospital Affiliated Fudan University
Shanghai , Shanghai Municipality
Tianjin Medical University Cancer Institute and Hospital
Tianjin , Tianjin Municipality
The Second Hospital of Tianjin Medical University
Tianjin , Tianjin Municipality
Xinjiang Medical University Cancer Hospital - Urumqi
Ürümqi , Xinjiang
Wuhan Union Hospital
Wuhan , Hubei
Tongji Hospital Tongji Medical,Science & Technology
Wuhan , Hubei
Wannan Medical College Yijishan Hospital
Wuhu , Anhui
Wuxi People's Hospital
Wuxi , Jiangsu
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , Shaanxi
Yantai Yuhuangding Hospital
Yantai , Shandong
Дания (2)
Rigshospitalet
Copenhagen , Capital Region
Næstved Sygehus
Næstved , Region Sjælland
Франция (6)
CHU de Bordeaux Hop St ANDRE
Bordeaux
Henri Mondor Hospital
Créteil , Île-de-France Region
CHD Vendee
La Roche-sur-Yon , Vendée
Clinique Victor Hugo Le Mans
Le Mans , Pays de la Loire Region
Centre Leon Berard
Lyon , Auvergne-Rhône-Alpes
Centre de Cancérologie du Grand Montpellier
Montpellier , Languedoc-Roussillon
Германия (9)
Studienzentrum Bayenthal Urologische Partnerschaft Köln
Cologne , North Rhine-Westphalia
Private Practice - Dr. Ralf Eckert
Eisleben Lutherstadt , Saxony-Anhalt
Gesundheitszentrum Holzminden
Holzminden , Lower Saxony
Private Practice - Dr. Silvio Szymula
Leipzig , Saxony
Urologie Neandertal - Praxis Mettmann
Mettmann , North Rhine-Westphalia
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster , North Rhine-Westphalia
Studienpraxis Urologie
Nürtingen , Baden-Wurttemberg
Universitaetsklinikum Tuebingen
Tübingen , Baden-Wurttemberg
Private Practice - Dr. Stammel & Dr. Garcia
Wesel , North Rhine-Westphalia
Япония (13)
Gifu University Hospital
Gifu
Hamamatsu University Hospital
Hamamatsu , Shizuoka
Hirosaki University Hospital
Hirosaki , Aomori
Saitama Prefectural Cancer Center
Ina-machi , Saitama
Kanazawa University Hospital
Kanazawa , Ishikawa-ken
Kobe City Medical Center General Hospital
Kobe , Hyōgo
National Hospital Organization Kumamoto Medical Center
Kumamoto
Japanese Red Cross Nagoya Daini Hospital
Nagoya , Aichi-ken
Osaka International Cancer Institute
Osaka
Toho University Sakura Medical Center
Sakura , Chiba
Hokkaido University Hospital
Sapporo , Hokkaido
Showa University Hospital
Shinagawa , Tokyo
Yokohama City University Medical Center
Yokohama , Kanagawa
Нидерландия (3)
Canisius-Wilhelmina Ziekenhuis
Nijmegen , Gelderland
Erasmus Medisch Centrum
Rotterdam , South Holland
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht
Румъния (3)
Gral Medical Diagnostic Center
Bucharest
Centrul de Oncologie "Sfântul Nectarie"
Craiova , Dolj
Ovidius Clinical Hospital OCH
Ovidiu , Constanța County
Южна Корея (4)
Seoul National University Hospital
Seoul , Seoul-teukbyeolsi [Seoul]
Severance Hospital, Yonsei University Health System
Seoul , Seoul-teukbyeolsi [Seoul]
Samsung Medical Center
Seoul , Seoul-teukbyeolsi [Seoul]
Asan Medical Center
Songpagu , Seoul-teukbyeolsi [Seoul]
Испания (7)
Hospital Universitari Vall d'Hebron
Barcelona , Barcelona [Barcelona]
Hospital Clínic de Barcelona
Barcelona , Catalunya [Cataluña]
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet , Barcelona [Barcelona]
Hospital Universitario Ramón y Cajal
Madrid , Madrid, Comunidad de
Hospital Universitario 12 de Octubre
Madrid , Madrid, Comunidad de
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario Virgen de la Victoria
Málaga , Málaga
САЩ (33)
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
Albany , New York
Northside Hospital
Atlanta , Georgia
CBCC Global Research, Inc.
Bakersfield , California
Massachusetts General Hospital
Boston , Massachusetts
The University of Vermont Medical Center Inc.
Burlington , Vermont
Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
Fort Wayne , Indiana
Providence St. Jude Medical Center
Fullerton , California
Millennium Oncology - Hollywood
Hollywood , Florida
St. Bernards Medical Center
Jonesboro , Arkansas
Moores Cancer Center
La Jolla , California
Comprehensive Cancer Centers of Nevada
Las Vegas , Nevada
Rocky Mountain Cancer Center
Lone Tree , Colorado
TRIO-US (Translational Research in Oncology-US)
Los Angeles , California
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles , California
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis , Minnesota
Pacific Cancer Care
Monterey , California
Research Medical Center
Nashville , Tennessee
St. Joseph's Hospital and Medical Center
Phoenix , Arizona
Mayo Clinic in Arizona - Phoenix
Phoenix , Arizona
Huntsman Cancer Institute
Salt Lake City , Utah
Sansum Clinic_Kendle
Santa Barbara , California
Associated Medical Professionals - Urology
Syracuse , New York
Baylor Scott & White Medical Center - Temple
Temple , Texas
New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
The Woodlands , Texas
Northwest Cancer Specialists PC
The Woodlands , Texas
Sansum Clinic_Kendle
The Woodlands , Texas
Texas Oncology - Longview Cancer Center
The Woodlands , Texas
Texas Oncology Cancer Care and Research Center
The Woodlands , Texas
Texas Oncology Fort Worth
The Woodlands , Texas
Texas Oncology-Memorial City
The Woodlands , Texas
US Oncology
The Woodlands , Texas
USO-Cancer Care Center of Brevard, Inc.
The Woodlands , Texas
The University of Arizona Cancer Center - North Campus
Tucson , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
26.11.2018
Крайна дата
01.06.2026
Регистрационен номер
NCT03706365
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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