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JOURNAL ONKOLOGIE – STUDIE
TALAPRO-2

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

Rekrutierend

NCT-Nummer:
NCT03395197

Studienbeginn:
Dezember 2017

Letztes Update:
20.04.2021

Wirkstoff:
Talazoparib with enzalutamide, Placebo with enzalutamide

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Pfizer

Collaborator:
Astellas Pharma Inc

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 396)

Universitatsklinikum Erlangen Medizinische Klinik 5
91054 Erlangen
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Duesseldorf
40225 Duesseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Erlangen, Urologische und Kinderurologische Klinik
91054 Erlangen
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Hamburg-Eppendorf
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Universitaetsklinik Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Diagnostikzentrum
73230 Kirchheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Muenster
48149 Muenster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Studienpraxis Urologie
72622 Nuertingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Labor Dr. Gartner
88212 Ravensburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Laborgemeinschaft Reutlingen
72770 Reutlingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Kliniken Nordoberpfalz AG
92637 Weiden
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Alaska Urological Institute dba Alaska Clinical Research Center
99503 Anchorage
United StatesAbgebrochen» Google-Maps
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
85224 Chandler
United StatesRekrutierend» Google-Maps
Banner Gateway Medical Center
85234 Gilbert
United StatesNoch nicht rekrutierend» Google-Maps
Banner MD Anderson Cancer Center
85234 Gilbert
United StatesNoch nicht rekrutierend» Google-Maps
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
85297 Gilbert
United StatesRekrutierend» Google-Maps
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
85202 Mesa
United StatesRekrutierend» Google-Maps
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
85206 Mesa
United StatesRekrutierend» Google-Maps
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
85260 Scottsdale
United StatesRekrutierend» Google-Maps
Urological Associates of Southern Arizona, PC
85715 Tucson
United StatesRekrutierend» Google-Maps
Urological Associates of Southern Arizona, P.C.
85741 Tucson
United StatesRekrutierend» Google-Maps
Beverly Hills Cancer Center
90211 Beverly Hills
United StatesRekrutierend» Google-Maps
South County Hematology/Oncology
91911 Chula Vista
United StatesRekrutierend» Google-Maps
Glendale Adventist Medical Center
91206 Glendale
United StatesRekrutierend» Google-Maps
Marin Cancer Care, Inc.
94904 Greenbrae
United StatesRekrutierend» Google-Maps
Cancer Center Oncology Medical Group
91942 La Mesa
United StatesRekrutierend» Google-Maps
Loma Linda University Cancer Center - Hematology/Oncology Clinic
92354 Loma Linda
United StatesNoch nicht rekrutierend» Google-Maps
Loma Linda University Medical Center
92354 Loma Linda
United StatesNoch nicht rekrutierend» Google-Maps
VA Long Beach Healthcare System
90822 Long Beach
United StatesRekrutierend» Google-Maps
UCLA Clark Urology Center
90095 Los Angeles
United StatesRekrutierend» Google-Maps
University of California, Irvine Medical Center
92868 Orange
United StatesRekrutierend» Google-Maps
Stanford Cancer Institute
94304 Palo Alto
United StatesRekrutierend» Google-Maps
Desert Hematology Oncology Medical Group, Incorporation
92270 Rancho Mirage
United StatesRekrutierend» Google-Maps
Eisenhower Medical Center
92270 Rancho Mirage
United StatesRekrutierend» Google-Maps
Medical Oncology Associates-SD
92123 San Diego
United StatesRekrutierend» Google-Maps
Sharp Memorial Hospital Investigational Pharmacy
92123 San Diego
United StatesRekrutierend» Google-Maps
University of Colorado Denver CTO/CTRC
80045 Aurora
United StatesRekrutierend» Google-Maps
University of Colorado Hospital - Anschutz Cancer Pavilion
80045 Aurora
United StatesRekrutierend» Google-Maps
University of Colorado Hospital- Anschutz Inpatient Pavilion
80045 Aurora
United StatesRekrutierend» Google-Maps
University of Colorado Hospital- Anschutz Outpatient Pavilion
80045 Aurora
United StatesRekrutierend» Google-Maps
University of Colorado Hospital
80045 Aurora
United StatesRekrutierend» Google-Maps
The Urology Center of Colorado
80211 Denver
United StatesRekrutierend» Google-Maps
Danbury Hospital
06810 Danbury
United StatesNoch nicht rekrutierend» Google-Maps
New Milford Hospital
06776 New Milford
United StatesNoch nicht rekrutierend» Google-Maps
Norwalk Hospital
06856 Norwalk
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32701 Altamonte Springs
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34135 Bonita Springs
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34211 Bradenton
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33511 Brandon
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33909 Cape Coral
United StatesNoch nicht rekrutierend» Google-Maps
AdventHealth Medical Group Hematology & Oncology at Celebration
34747 Celebration
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33761 Clearwater
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32117 Daytona Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33901 Fort Myers
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33905 Fort Myers
United StatesNoch nicht rekrutierend» Google-Maps
21st Century Oncology
33908 Fort Myers
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33908 Fort Myers
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32605 Gainesville
United StatesNoch nicht rekrutierend» Google-Maps
AdventHealth Medical Group Hematology & Oncology at Kissimmee
34741 Kissimmee
United StatesRekrutierend» Google-Maps
Lakeland Regional Health Hollis Cancer Center
33805 Lakeland
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33770 Largo
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34461 Lecanto
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34102 Naples
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34655 New Port Richey
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34471 Ocala
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32763 Orange City
United StatesNoch nicht rekrutierend» Google-Maps
AdventHealth Hematology and Oncology
32804 Orlando
United StatesRekrutierend» Google-Maps
Investigational Drug Services, Advent Health Orlando
32804 Orlando
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32806 Orlando
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33980 Port Charlotte
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33705 Saint Petersburg
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34232 Sarasota
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34236 Sarasota
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34608 Spring Hill
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33607 Tampa
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32778 Tavares
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32159 The Villages
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34285 Venice
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34292 Venice
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialists
32960 Vero Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33414 Wellington
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33401 West Palm Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32792 Winter Park
United StatesNoch nicht rekrutierend» Google-Maps
University Cancer & Blood Center, LLC
30607 Athens
United StatesNoch nicht rekrutierend» Google-Maps
Piedmont Cancer Institute
30318 Atlanta
United StatesRekrutierend» Google-Maps
Emory University Hospital
30322 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
The Emory Clinic
30322 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Winship Cancer Institute Emory University
30322 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Piedmont Cancer Institute
30214 Fayetteville
United StatesRekrutierend» Google-Maps
Piedmont Cancer Institute
30265 Newnan
United StatesRekrutierend» Google-Maps
Southeastern Regional Medical Center
30265 Newnan
United StatesAktiv, nicht rekrutierend» Google-Maps
Cook County Health (CCH)
60612 Chicago
United StatesRekrutierend» Google-Maps
John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
60612 Chicago
United StatesRekrutierend» Google-Maps
Rush University Medical Center Professional Office Building Infusion Pharmacy
60612 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Rush University Medical Center
60612 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
AMITA Health Adventist Medical Center Hinsdale
60521 Hinsdale
United StatesRekrutierend» Google-Maps
AMITA Health Cancer Institute
60521 Hinsdale
United StatesRekrutierend» Google-Maps
Midwestern Regional Medical Center
60099 Zion
United StatesRekrutierend» Google-Maps
First Urology, PSC
47130 Jeffersonville
United StatesRekrutierend» Google-Maps
University of Iowa Hospitals and Clinics
52242 Iowa City
United StatesAktiv, nicht rekrutierend» Google-Maps
The University of Kansas Clinical Research Center
66205 Fairway
United StatesRekrutierend» Google-Maps
The University of Kansas Cancer Center
66205 Westwood
United StatesRekrutierend» Google-Maps
Ochsner Clinic Foundation
70121 New Orleans
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Maryland Greenebaum Comprehensive Cancer Center
21201 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
VA Saint Louis Healthcare System
63106 Saint Louis
United StatesNoch nicht rekrutierend» Google-Maps
St. Vincent Healthcare
59101 Billings
United StatesNoch nicht rekrutierend» Google-Maps
St. Vincent Frontier Cancer Center
59102 Billings
United StatesNoch nicht rekrutierend» Google-Maps
Oncology Hematology West, PC dba Nebraska Cancer Specialists
68114 Omaha
United StatesNoch nicht rekrutierend» Google-Maps
Oncology Hematology West, PC dba Nebraska Cancer Specialists
68124 Omaha
United StatesNoch nicht rekrutierend» Google-Maps
GU Research Network/Urology Cancer Center
68130 Omaha
United StatesRekrutierend» Google-Maps
Oncology Hematology West, PC dba Nebraska Cancer Specialists
68130 Omaha
United StatesNoch nicht rekrutierend» Google-Maps
New Jersey Cancer Care and Blood Disorders
07109 Belleville
United StatesRekrutierend» Google-Maps
New Jersey Urology, LLC
08043 Voorhees
United StatesAktiv, nicht rekrutierend» Google-Maps
Urology Group of New Mexico
87109 Albuquerque
United StatesRekrutierend» Google-Maps
San Juan Oncology Associates
87401 Farmington
United StatesRekrutierend» Google-Maps
Montefiore Medical Center - Montefiore Medical Park
10461 Bronx
United StatesRekrutierend» Google-Maps
Premier Medical Group of the Hudson Valley PC
12601 Poughkeepsie
United StatesRekrutierend» Google-Maps
Associated Medical Professionals of New York, PLLC
13210 Syracuse
United StatesRekrutierend» Google-Maps
TriState urologic Services PSC Inc., dba The Urology Group
45212 Cincinnati
United StatesRekrutierend» Google-Maps
Clinical Research Solutions
44130 Middleburg Heights
United StatesRekrutierend» Google-Maps
Stephenson Cancer Center
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Kaiser Sunnyside Medical Center
97015-9303 Clackamas
United StatesRekrutierend» Google-Maps
Providence Cancer Institute Clackamas Clinic
97015 Clackamas
United StatesRekrutierend» Google-Maps
Kaiser Westside Medical Center
97124 Hillsboro
United StatesRekrutierend» Google-Maps
Providence Cancer Institute Newberg Clinic
97132 Newberg
United StatesRekrutierend» Google-Maps
Providence Cancer Institute Franz Clinic
97213 Portland
United StatesRekrutierend» Google-Maps
Providence Oncology and Hematology Care Clinic - Westside
97225 Portland
United StatesRekrutierend» Google-Maps
Kaiser Permanente Northwest
97227 Portland
United StatesRekrutierend» Google-Maps
Oregon Urology Institute
97477 Springfield
United StatesNoch nicht rekrutierend» Google-Maps
UPMC Hillman Cancer Center - Altoona
16601 Altoona
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center - Upper St. Clair
15102 Bethel Park
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center - Arnold Palmer - Mt View
15601 Greensburg
United StatesRekrutierend» Google-Maps
Keystone Urology Specialists
17604 Lancaster
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center - Monroeville
15146 Monroeville
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center - Passavant (HOA)
15237 Pittsburgh
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center - Passavant (OHA)
15237 Pittsburgh
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center - Northwest
16346 Seneca
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center - Uniontown
15401 Uniontown
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center - Washington
15301 Washington
United StatesRekrutierend» Google-Maps
Carolina Urologic Research Center
29572 Myrtle Beach
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute
37404 Chattanooga
United StatesRekrutierend» Google-Maps
Tennessee Oncology, PLLC
37404 Chattanooga
United StatesRekrutierend» Google-Maps
Tennesse Oncology, PLLC
37311 Cleveland
United StatesRekrutierend» Google-Maps
Tennessee Cancer Specialists-Harrogate
37752 Harrogate
United StatesNoch nicht rekrutierend» Google-Maps
Tennessee Cancer Specialists-Jefferson City
37760 Jefferson City
United StatesNoch nicht rekrutierend» Google-Maps
Center for Biomedical Research
37909 Knoxville
United StatesNoch nicht rekrutierend» Google-Maps
Tennessee Cancer Specialists
37909 Knoxville
United StatesNoch nicht rekrutierend» Google-Maps
Tennessee Cancer Specialists-Morristown
37813 Morristown
United StatesNoch nicht rekrutierend» Google-Maps
Urology Associates P.C.
37209 Nashville
United StatesRekrutierend» Google-Maps
The Vanderbilt Clinic
37232 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Vanderbuilt University Medical Center, Department of Urology
37232 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Urology Austin PLLC
78745 Austin
United StatesNoch nicht rekrutierend» Google-Maps
Rio Grande Urology, P.A.
79912 El Paso
United StatesRekrutierend» Google-Maps
Urology Austin, PLLC
78681 Round Rock
United StatesNoch nicht rekrutierend» Google-Maps
Baylor Scott and White Medical Center-Temple
76508 Temple
United StatesRekrutierend» Google-Maps
Farmington Health Center -University of Utah
84025 Farmington
United StatesRekrutierend» Google-Maps
Huntsman Cancer Hospital
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
University of Utah, Huntsman Cancer Institute
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
Redwood Health Center-University of Utah
84119 Salt Lake City
United StatesRekrutierend» Google-Maps
South Jordan Health Center -University of Utah
84095 South Jordan
United StatesRekrutierend» Google-Maps
Inova Schar Cancer Institute Infusion Pharmacy
22031 Fairfax
United StatesRekrutierend» Google-Maps
Inova Schar Cancer Institute
22031 Fairfax
United StatesRekrutierend» Google-Maps
Swedish Cancer Institute
98104 Seattle
United StatesAktiv, nicht rekrutierend» Google-Maps
Swedish Medical Center
98122 Seattle
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Wisconsin Clinical Science Center
53792 Madison
United StatesRekrutierend» Google-Maps
University of Wisconsin Hospital & Clinics
53792 Madison
United StatesRekrutierend» Google-Maps
Centro de Investigacion Pergamino SA - Clinica Pergamino SA
B2700CPM Pergamino
ArgentinaRekrutierend» Google-Maps
Instituto de Oncologia de Rosario
S2000KZE Rosario
ArgentinaRekrutierend» Google-Maps
Hospital Británico de Buenos Aires
C1280AEB Caba
ArgentinaRekrutierend» Google-Maps
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic
C1431FWO Caba
ArgentinaRekrutierend» Google-Maps
Clinica Universitaria Reina Fabiola
X5004FHP Cordoba
ArgentinaRekrutierend» Google-Maps
Hospital Privado Centro Medico de Cordoba
X5016KEH Cordoba
ArgentinaRekrutierend» Google-Maps
St Vincent's Hospital Sydney
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
Port Macquarie Base Hospital
2444 Port Macquarie
AustraliaRekrutierend» Google-Maps
ICON Cancer Centre Wesley
4066 Auchenflower
AustraliaRekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Brisbane
AustraliaRekrutierend» Google-Maps
ICON Cancer Centre Chermside
4032 Chermside
AustraliaRekrutierend» Google-Maps
ICON Cancer Centre South Brisbane
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
Integrated Clinical Oncology Network Pty Ltd (ICON)
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
ICON Cancer Centre Southport
4215 Southport
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3051 North Melbourne
AustraliaRekrutierend» Google-Maps
Clinique Saint-Pierre Ottignies
1340 Ottignies
BelgiumRekrutierend» Google-Maps
Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
20230-130 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
20231-050 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Hospital Gloria D'Or
22211-230 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Instituto D'Or de Pesquisa e Ensino
22281-100 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Associacao Hospital de Caridade de Ijui
98700-000 Ijui
BrazilRekrutierend» Google-Maps
Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born
95900-022 Lajeado
BrazilRekrutierend» Google-Maps
Centro de Pesquisa Clinica de Oncologia e Hematologia/Hospital Mae de Deus
90110-000 Porto Alefre
BrazilRekrutierend» Google-Maps
Centro de Pesquisa Clinica de Oncologia e Hematologia/Hospital Mae de Deus
90110-270 Porto Alegre
BrazilRekrutierend» Google-Maps
Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica
90610-000 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao
91350-200 Porto Alegre
BrazilRekrutierend» Google-Maps
Fundacao Pio XII - Hospital de Cancer de Barretos
14784-400 Barretos
BrazilRekrutierend» Google-Maps
Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)
09060-650 Santo Andre
BrazilRekrutierend» Google-Maps
Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)
09060-870 Santo Andre
BrazilRekrutierend» Google-Maps
Instituto do Cancer do Estado de Sao Paulo - ICESP
01246-000 Sao Paulo
BrazilRekrutierend» Google-Maps
Instituto do Cancer do Estado de Sao Paulo-ICESP-Nucleo de Pesquisa
01246-000 Sao Paulo
BrazilRekrutierend» Google-Maps
Sociedade Beneficente de Senhoras Hospital Sírio Libanês
01308-050 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Alemão Oswaldo Cruz
01327-001 Sao Paulo
BrazilRekrutierend» Google-Maps
Tom Baker Cancer Centre - Alberta Health Services
T2N 4N2 Calgary
CanadaRekrutierend» Google-Maps
The Ottawa Hospital Cancer Center
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
G7H 5H6 Chicoutimi
CanadaRekrutierend» Google-Maps
CHUM - Centre Hospitalier de l'Universite de Montreal
H2X 3E4 Montreal
CanadaRekrutierend» Google-Maps
Centre integre universitaire de sante et de services sociaux de l'Estrie
J1H 5N4 Sherbrooke
CanadaRekrutierend» Google-Maps
Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia)
7500713 Santiago
ChileRekrutierend» Google-Maps
Centro de Investigacion Clinica del Sur
4781156 Temuco
ChileRekrutierend» Google-Maps
Sociedad de Investigaciones Medicas Ltda (SIM)
4810469 Temuco
ChileRekrutierend» Google-Maps
Sociedad de Investigaciones Medicas Ltda (SIM)
4810561 Temuco
ChileRekrutierend» Google-Maps
Centro de Investigaciones Clinicas Vina del Mar
2540488 Vina del Mar
ChileRekrutierend» Google-Maps
Centro de Investigaciones Clinicas Vina del Mar
2540634 Vina del Mar
ChileRekrutierend» Google-Maps
The First affiliated Hospital of Anhui Medical University
230022 Hefei
ChinaRekrutierend» Google-Maps
Peking University First Hospital / Urology Department
100034 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Peking University Third Hospital
100191 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Fujian Medical University
350005 Fuzhou
ChinaRekrutierend» Google-Maps
First Affiliated Hospital of Xiamen University
361003 Xiamen
ChinaNoch nicht rekrutierend» Google-Maps
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
430022 Wuhan
ChinaRekrutierend» Google-Maps
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
430030 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
210008 Nanjing
ChinaRekrutierend» Google-Maps
Second Affiliated Hospital of Suzhou University
215004 Suzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Nanchang University
330006 Nanchang
ChinaRekrutierend» Google-Maps
Zhongshan Hospital Fudan University
200032 Shanghai
ChinaRekrutierend» Google-Maps
Huashan Hospital Fudan University
200040 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps
West China Hospital of Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps
Zhejiang Provincial People's Hospital
310014 Hangzhou
ChinaRekrutierend» Google-Maps
Chongqing University Cancer Hospital
400030 Chongqing
ChinaRekrutierend» Google-Maps
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
200025 Shanghai
ChinaRekrutierend» Google-Maps
Fudan University Cancer Hospital, Deptartment of Urology
200032 Shanghai
ChinaRekrutierend» Google-Maps
The Fifth People's Hospital of Shanghai, Fudan University
201100 Shanghai
ChinaRekrutierend» Google-Maps
The Second Hospital of Tianjin Medical University
300211 Tianjin
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80131 Napoli
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Alle anzeigen

Studien-Informationen

Detailed Description:

Part 1 is an open-label, non-randomized, safety and PK run-in study designed to confirm the

starting dose of talazoparib in combination with enzalutamide through assessment of target

safety events and PK at select sites. Part 2 is a randomized, double-blind,

placebo-controlled, multinational study comparing talazoparib plus enzalutamide vs. placebo

plus enzalutamide in patients with mCRPC.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate withoutsmall cell

or signet cell features

Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC)

(score on BPI-SF Question #3 must be < 4).

For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status

Consent to a saliva sample collection for a germline comparator unless prohibited by local

regulations or ethics committee decision (optional for patients in Part 1).

Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at

screening.

Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI

scan.

Progressive disease at study entry in the setting of medical or surgical castration as

defined by 1 or more of the following 3 criteria:

- Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA

values from 3 consecutive assessments with an interval of at least 7 days between

assessments..

- Soft tissue disease progression as defined by RECIST 1.1.

- Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or

more new metastatic bone lesions on a whole body radionuclide bone scan.

Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2)

is allowed but not mandatory.

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

Life expectancy ≥ 12 months as assessed by the investigator.

Able to swallow the study drug and have no known intolerance to study drugs or excipients.

Must agree to use a condom when having sex with a partner from the time of the first dose

of study drug through 4 months after last dose of study treatment. Must also agree for

female partner of childbearing potential to use an additional highly effective form of

contraception from the time of the first dose of study treatment through 4 months after

last dose of study treatment when having sex with a non pregnant female partner of

childbearing potential.

Must agree not to donate sperm from the first dose of study drug to 4 months after the last

dose of study drug.

Evidence of a personally signed and dated informed consent document (and molecular

prescreening consent if appropriate) indicating that the patient [or a legally acceptable

representative/legal guardian] has been informed of all pertinent aspects of the study.

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and

other study procedures

Exclusion Criteria:

Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC

disease state.

Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation.

Prior treatment with second-generation androgen receptor inhibitors (enzalutamide,

apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for

prostate cancer.

Prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior

to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on

platinum-based therapy within 6 months (from the last dose).

Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T, or

radionuclide therapy received in the castration-sensitive prostate cancer is NOT

exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part

2).

Treatment with any investigational agent within 4 weeks before Day 1 (Part 1) or

randomization (Part 2).

Prior treatment with opioids for pain related to either primary prostate cancer or

metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2).

Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or

randomization (Part 2).

Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or

randomization (Part 2), or palliative localized radiation therapy within 3 weeks before

randomization (Part 2).

Clinically significant cardiovascular disease

Significant renal dysfunction as defined by any of the following laboratory abnormalities:

• Renal: eGFR < 30 mL/min/1.73 m2 by the MDRD equation (available via www.mdrd.com).

Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at

screening.

Significant hepatic dysfunction as defined by any of the following laboratory abnormalities

on screening labs:

- Total serum bilirubin >1.5 times the upper limit of normal (ULN) (>3 × ULN for

patients with documented Gilbert syndrome or for whom indirect bilirubin

concentrations suggest an extrahepatic source of elevation).

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN (>5

× ULN if liver function abnormalities are due to hepatic metastasis).

- Albumin <2.8 g/dL

Absolute neutrophil count < 1500/µL, platelets < 100,000/µL, or hemoglobin < 9 g/dL (may

not have received growth factors or blood transfusions within 14 days before obtaining the

hematology values at screening).

Known or suspected brain metastasis or active leptomeningeal disease.

Symptomatic or impending spinal cord compression or cauda equina syndrome.

Any history of myelodysplastic syndrome, acute myeloid leukemia, or prior malignancy except

any of the following:

- Carcinoma in situ or non melanoma skin cancer

- Any prior malignancies ≥3 years before randomization with no subsequent evidence of

recurrence or progression regardless of the stage.

- Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability

of recurrence or progression in the opinion of the investigator

Gastrointestinal disorder affecting absorption.

Fertile male subjects who are unwilling or unable to use highly effective methods of

contraception for the duration of the study and for 4 months after the last dose of

investigational product.

Investigator site staff members directly involved in the conduct of the study and their

family members, site staff members otherwise supervised by the investigator, or patients

who are Pfizer employees, including their family members, directly involved in the conduct

of the study.

Other acute or chronic medical (concurrent disease, infection, or comorbidity) or

psychiatric condition including recent (within the past year) or active suicidal ideation

or behavior or laboratory abnormality that interferes with ability to participate in the

study, may increase the risk associated with study participation or investigational product

administration, or may interfere with the interpretation of study results and, in the

judgment of the investigator, would make the patient inappropriate for entry into this

study.

History of seizure or any condition that may predispose to seizure (eg, prior cortical

stroke, significant brain trauma). Also, history of loss of consciousness or transient

ischemic attack within 12 months of randomization (Part 2).

Studien-Rationale

Primary outcome:

1. Confirm the dose of Talazoparib (part 1) (Time Frame - Day 1 up to 28 days):
determined based on the safety profile

2. Radiographic PFS (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - randomization up to 25 months):
time from the date of randomization to first objective evidence of radiographic progression by blinded independent review, or death (occurring within 168 days of treatment discontinuation), whichever occurs first

Secondary outcome:

1. Overall survival (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - randomization up to 47 months):
time from randomization to death from any cause

2. Objective response in measurable soft tissue disease (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - baseline up to 6 months):
proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1

3. Duration of soft tissue response (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - baseline up to 25 months):
duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1

4. PSA response (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - baseline up to 25 months):
proportion of patients with PSA response grater than or equal to 50%

5. Time to PSA progression (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - baseline up to 25 months):
time from baseline to PSA progression

6. Time to initiation of cytotoxic chemotherapy (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - randomization up to 47 months):
time from randomization to initiation of cytotoxic chemotherapy

7. Time to initiation of antineoplastic therapy (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - randomization up to 47 months):
time from randomization to initiation of antineoplastic treatment

8. Time to first symptomatic skeletal event (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - randomization up to 47 months):
time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first)

9. PFS on next line of therapy (PFS2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - randomization up to 47 months):
PFS2 based on investigator assessment

10. Opiate use for cancer pain (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - randomization up to 47 months):
time from randomization to opiate use for prostate cancer pain

11. Incidence of adverse events (part 1 and 2) (Time Frame - Day 1 up to 26 months):
AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)

12. Pharmacokinetic assessment of talazoparib (part 1) (Time Frame - Week 1, 5, 9, and 13):
plasma concentration of talazoparib

13. Pharmacokinetic assessment of talazoparib (part 2) (Time Frame - week 3, 5, 9 13, and 17):
plasma concentration of talazoparib

14. Pharmacokinetic assessment of enzalutamide (part 1) (Time Frame - week 1, 5, 9, and 13):
plasma concentration of enzalutamide

15. Pharmacokinetic assessment of enzalutamide (part 2) (Time Frame - week 3, 5, 9 13, and 17):
plasma concentration of enzalutamide

16. Patient-reported outcome:pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - baseline up to 47 months):
change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)

17. Patient-reported outcome: pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - baseline up to 47 months):
time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)

18. Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - baseline up to 47 months):
change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30

19. Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies (Time Frame - baseline up to 47 months):
time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30

20. Patient-reported outcome: general health status (part2) in unselected patients and patients harboring DDR deficiencies (Time Frame - baseline up to 47 months):
change from baseline in patient-reported general health status per EQ-5D-5L

21. Patient-reported outcome: general health status (part 2) in unselected patients and patients harboring DDR deficiencies (Time Frame - baseline up to 47 months):
time to definitive deterioration in patient-reported disease-specific urinary symptoms per EORTC QLQ-PR25

Studien-Arme

  • Experimental: Combination arm
    Talazoparib plus enzalutamide
  • Active Comparator: Monotherapy arm
    Ezalutamide plus placebo

Geprüfte Regime

  • Talazoparib with enzalutamide:
    Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
  • Placebo with enzalutamide:
    Placebo plus enzalutamide 160 mg/day

Quelle: ClinicalTrials.gov


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