A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Phase 3 – large-scale trial before approval
Conditions:
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Sponsor: Pfizer
trial.available_in:
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Overview
Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.
Who can participate
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
* Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
Exclusion Criteria:
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.
* Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
* Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment, with the following exceptions:
1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
* Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
* Inadequate organ function.
Interventions
PF-06821497
DRUG
Docetaxel
DRUG
Enzalutamide
DRUG
Locations
234
Argentina (8)
IMAXE
Buenos Aires
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires
Centro de Urología (CDU)
CABA , Buenos Aires
Centro Medico Privado CEMAIC
Capital , Córdoba Province
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires , Buenos Aires
Imagenes Mdq
Mar del Plata , Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata , Buenos Aires
Australia (3)
Icon Cancer Centre Wesley
Auchenflower , Queensland
Monash Health
Clayton , Victoria
Peter MacCallum Cancer Centre
Melbourne , Victoria
Brazil (9)
Hospital São Carlos
Fortaleza , Ceará
Crio - Centro Regional Integrado de Oncologia
Fortaleza , Ceará
Hospital São Lucas da PUCRS
Porto Alegre , Rio Grande do Sul
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André , São Paulo
Hospital de Base de São José do Rio Preto
São José do Rio Preto , São Paulo
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto , São Paulo
Hospital Alemao Oswaldo Cruz
São Paulo , São Paulo
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo
IBCC - Núcleo de Pesquisa e Ensino
São Paulo
Canada (4)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary , Alberta
Centre Hospitalier de l'Université de Montréal
Montreal , Quebec
Sunnybrook Research Institute
Toronto , Ontario
BC Cancer Vancouver
Vancouver , British Columbia
China (27)
Beijing Friendship Hospital, Capital Medical University
Beijing , Beijing Municipality
Peking University Third Hospital
Beijing , Beijing Municipality
Hunan Cancer Hospital
Changsha , Hunan
West China Hospital, Sichuan University
Chengdu , Sichuan
Chongqing University Cancer Hospital
Chongqing , Chongqing Municipality
Fujian Medical University Union Hospital
Fuzhou , Fujian
Fujian Cancer Hospital
Fuzhou , Fujian
Guangzhou First People's Hospital
Guangzhou , Guangdong
Southern Medical University Nanfang Hospital
Guangzhou , Guangdong
The Second Affiliated Hospital of Guilin Medical University
Guilin , Guangxi
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou , Zhejiang
Huai'an First People's Hospital
Huai'an , Jiangsu
The First Hospital of Jiaxing
Jiaxing , Zhejiang
Lanzhou university second hospital
Lanzhou , Gansu
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing , Jiangsu
Nantong Tumor Hospital
Nantong , Jiangsu
The first affiliated hospital of Ningbo university
Ningbo , Zhejiang
Tongji Hospital of Tongji University
Shanghai , Shanghai Municipality
The First Hospital of China Medical University
Shenyang , Liaoning
The First Hospital of China Medical University
Shenyang , Liaoning
The Second Affiliated Hospital of Soochow University
Suzhou , Jiangsu
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , Zhejiang
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan , Hubei
Wannan Medical College Yijishan Hospital
Wuhu , Anhui
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , Shaanxi
Shaanxi Provincial People' Hospital
Xi'an , Shaanxi
Yantai Yuhuangding Hospital
Yantai , Shandong
Czech Republic (6)
Nukleární Medicína
Hradec Králové
Fakultni nemocnice Olomouc
Olomouc , Olomouc Region
Multiscan
Pardubice , Pardubice Region
Radiodiagnostika Pardubice
Pardubice
Fakultni nemocnice Kralovske Vinohrady
Prague , Praha 10
Fakultni Thomayerova nemocnice
Prague , Praha 4
France (14)
CHRU de Brest
Brest , Finistère
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand
Centre Oscar Lambret
Lille , Hauts-de-France
Centre Leon Berard
Lyon Cedex08 , Auvergne-Rhône-Alpes
Centre Antoine Lacassagne
Nice , Alpes-maritimes
Centre Antoine-Lacassagne
Nice , Alpes-maritimes
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire
Nîmes , GARD
Centre Hospitalier Lyon Sud
Pierre-Bénite , Rhône
Institut Jean Godinot
Reims , Marne
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire , Ille-et-vilaine
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg , Bas-rhin
Hôpital Foch
Suresnes , Hauts-de-seine
Oncopole Claudius Regaud
Toulouse , Haute-garonne
Gustave Roussy
Villejuif , Val-de-marne
Germany (5)
Universitaetsklinikum Hamburg-Eppendorf
Hamburg
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
Greece (4)
Alexandra General Hospital of Athens
Athens , Attikí
Athens Medical Center
Athens , Attikí
Metropolitan General Hospital
Athens , Attikí
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári , Attikí
Hungary (2)
Országos Onkológiai Intézet
Budapest , Pest County
Petz Aladar Egyetemi Oktato Korhaz
Győr , Győr-Moson-Sopron
Italy (3)
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola , Emilia-Romagna
Ospedale San Raffaele
Milan
Istituto Nazionale Tumori Regina Elena
Rome , Lazio
Japan (15)
Chiba cancer center
Chiba , Chiba
National Hospital Organization Kyushu Cancer Center
Fukuoka
Kanazawa University Hospital
Kanazawa , Ishikawa-ken
National Cancer Center Hospital East
Kashiwa , Chiba
Kobe University Hospital
Kobe , Hyōgo
National Hospital Organization Kumamoto Medical Center
Kumamoto
National Hospital Organization Shikoku Cancer Center
Matsuyama , Ehime
Osaka International Cancer Institute
Osaka
National Hospital Organization Hokkaido Cancer Center
Sapporo , Hokkaido
Hokkaido University Hospital
Sapporo , Hokkaido
Keio university hospital
Shinjuku-ku , Tokyo
The University of Osaka Hospital
Suita , Osaka
Yamagata University Hospital
Yamagata
Yokohama City University Medical Center
Yokohama , Kanagawa
Yokosuka Kyosai Hospital
Yokosuka , Kanagawa
Netherlands (4)
Meander Medisch Centrum
Amersfoort , Utrecht
Tergooi MC
Hilversum , North Holland
Frisius Medisch Centrum
Leeuwarden , Provincie Friesland
Canisius-Wilhelmina Ziekenhuis
Nijmegen , Gelderland
Poland (7)
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego
Grudziądz , Kuyavian-Pomeranian Voivodeship
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow , Lesser Poland Voivodeship
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow , Lesser Poland Voivodeship
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole , Opole Voivodeship
MICS Centrum Medyczne Torun
Torun , Kuyavian-Pomeranian Voivodeship
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Wroclaw , Lower Silesian Voivodeship
Slovakia (5)
Narodny onkologicky ustav
Bratislava
Vychodoslovensky onkologicky ustav, a.s.
Košice
MILAB, s.r.o., Urologicka ambulancia
Prešov
BEKY - MED, s.r.o.
Prešov
Fakultna nemocnica Trnava
Trnava
South Africa (4)
TASK Eden
George , Western Cape
Wits Clinical Research
Johannesburg , Gauteng
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth , Eastern Cape
Wilgers Oncology Centre
Pretoria , Gauteng
South Korea (8)
Kyungpook National University Chilgok Hospital
Daegu , Taegu-kwangyǒkshi
National Cancer Center
Goyang-si , Kyǒnggi-do
Chonnam National University Hwasun Hospital
Hwasun , Jeonranamdo
Seoul National University Hospital
Seoul , Seoul-teukbyeolsi [seoul]
Severance Hospital, Yonsei University Health System
Seoul , Seoul-teukbyeolsi [seoul]
Asan Medical Center
Seoul , Seoul-teukbyeolsi [seoul]
Samsung Medical Center
Seoul , Seoul-teukbyeolsi [seoul]
Ewha Womans University Mokdong Hospital
Seoul , Seoul-teukbyeolsi [seoul]
Spain (10)
Hospital Clínic de Barcelona
Barcelona , Catalunya [cataluña]
Hospital de la Santa Creu i Sant Pau
Barcelona , Catalunya [cataluña]
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat , 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 Fundación Jiménez Díaz
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa
Hospital Universitari i Politecnic La Fe
Valencia
Sweden (2)
Sahlgrenska Universitetssjukhuset
Gothenburg , Västra Götalands LÄN [se-14]
Södersjukhuset
Stockholm , Stockholms LÄN [se-01]
Taiwan (6)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
Turkey (10)
Adana City Hospital
Adana
Gulhane Egitim Arastirma Hastanesi
Ankara
Memorial Ankara Hastanesi
Ankara
Gazi University Health Research and Application Center Gazi Hospital
Ankara
Ankara University Health Practice and Research Hospitals
Ankara
I.E.U. Medical Point Hastanesi
Cordaleo , İzmir
Koç Üniversitesi Hastanesi
Istanbul , İ̇stanbul
Istanbul Universitesi Cerrahpasa
Istanbul , İ̇stanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul , İ̇stanbul
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul , İ̇stanbul
United Kingdom (7)
Royal Blackburn Hospital
Blackburn , Blackburn WITH Darwen
ACTIVE_NOT_RECRUITING
Western General Hospital
Edinburgh , Midlothian
The Beatson West of Scotland Cancer Centre
Glasgow
ACTIVE_NOT_RECRUITING
University College London Hospitals NHS Trust
London
ACTIVE_NOT_RECRUITING
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral
Singleton Hospital
Swansea
ACTIVE_NOT_RECRUITING
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea , Essex
ACTIVE_NOT_RECRUITING
United States (71)
Los Angeles Cancer Network
Anaheim , California
University of Miami Sylvester Comprehensive Cancer Center - Aventura
Aventura , Florida
UCSF Cancer Center Berkeley
Berkeley , California
Florida Cancer Specialists
Bonita Springs , Florida
Florida Cancer Specialists
Bradenton , Florida
UCSF Cancer Center Burlingame
Burlingame , California
Florida Cancer Specialists
Cape Coral , Florida
AtlantiCare Health Park - Cape May Court House
Cape May Court House , New Jersey
Ironwood Cancer & Research Centers
Chandler , Arizona
University of Miami Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables , Florida
University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach
Deerfield Beach , Florida
University of Miami Hospital and Clinics - Doral
Doral , Florida
AtlantiCare
Egg Harbor , New Jersey
Florida Cancer Specialists
Fort Myers , Florida
Florida Cancer Specialists
Fort Myers , Florida
Los Angeles Cancer Network
Fountain Valley , California
Ironwood Cancer & Research Centers
Gilbert , Arizona
Ironwood Cancer & Research Centers
Glendale , Arizona
Los Angeles Cancer Network
Glendale , California
Los Angeles Cancer Network
Glendale , California
Urology Centers of Alabama
Homewood , Alabama
University of Miami Sylvester Comprehensive Cancer Center - Kendall
Kendall , Florida
Colorado Clinical Research
Lakewood , Colorado
The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
Lancaster , Pennsylvania
Duly Health and Care
Lisle , Illinois
NextStage Clinical Research-Chicago-(04)
Lisle , Illinois
Los Angeles Cancer Network
Los Angeles , California
Los Angeles Cancer Network
Los Angeles , California
The University of Louisville, James Graham Brown Cancer Center
Louisville , Kentucky
University of Louisville Hospital
Louisville , Kentucky
UofL Health Medical Center Northeast
Louisville , Kentucky
Ironwood Cancer & Research Centers
Mesa , Arizona
Ironwood Cancer & Research Centers
Mesa , Arizona
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami , Florida
University of Miami Hospital and Clinics, UHealth Tower
Miami , Florida
University of Miami Sylvester Comprehensive Cancer Center - Griffin Cancer Research Building
Miami , Florida
Circuit Clinical /Crystal Run Healthcare LLP
Middletown , New York
Circuit Clinical
Middletown , New York
Crystal Run Healthcare
Monroe , New York
AUC Urologists, LLC
Myrtle Beach , South Carolina
Carolina Urologic Research Center, LLC
Myrtle Beach , South Carolina
Grand Strand Medical Center
Myrtle Beach , South Carolina
Parkway Surgery Center
Myrtle Beach , South Carolina
Florida Cancer Specialists
N. Venice , Florida
Florida Cancer Specialists
Naples , Florida
Sarah Cannon Research Institute, LLC
Nashville , Tennessee
SCRI Oncology Partners
Nashville , Tennessee
AdventHealth Hematology and Oncology
Orlando , Florida
AdventHealth Orlando Infusion Center
Orlando , Florida
Stanford Cancer Center
Palo Alto , California
Ironwood Cancer & Research Centers
Phoenix , Arizona
University of Miami Sylvester Comprehensive Cancer Center - Plantation
Plantation , Florida
Florida Cancer Specialists
Port Charlotte , Florida
Salisbury VA Medical Center
Salisbury , North Carolina
Huntsman Cancer Institute
Salt Lake City , Utah
USA Clinical Trials
San Antonio , Texas
UCSF Investigational Drug Pharmacy
San Francisco , California
UCSF Medical Center at Mission Bay
San Francisco , California
UCSF Cancer Center San Mateo
San Mateo , California
Sutter Santa Rosa
Santa Rosa , California
Florida Cancer Specialists
Sarasota , Florida
Ironwood Cancer & Research Centers
Scottsdale , Arizona
Harborview Medical Center
Seattle , Washington
Fred Hutchinson Cancer Center
Seattle , Washington
University of Washington Medical Center - Montlake
Seattle , Washington
VA St. Louis Health Care System
St Louis , Missouri
Stanford Health Care Attention: Investigational Pharmacy
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