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Brief Title: A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
Official Title: TALAPRO-1: A PHASE 2, OPEN-LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE-BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)
Study ID: NCT03148795
Brief Summary: The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Arizona Oncology Associates, Tempe, Arizona, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States
City of Hope-Antelope Valley, Lancaster, California, United States
UC Irvine Health Investigational Drug Pharmacy, Orange, California, United States
University of California, Irvine Medical Center, Orange, California, United States
Medical Oncology Associates-SD, San Diego, California, United States
Sharp Outpatient Infusion Therapy Center, San Diego, California, United States
Sharp Rees-Stealy, San Diego, California, United States
Emory University Hospital, Atlanta, Georgia, United States
The Emory Clinic, Atlanta, Georgia, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Piedmont Cancer Institute, PC, Fayetteville, Georgia, United States
Piedmont Cancer Institute, PC, Newnan, Georgia, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Christian Hospital North East, Saint Louis, Missouri, United States
Siteman Cancer Center - St. Peters, Saint Peters, Missouri, United States
Weill Cornell Medical Center - New York Presbyterian Hospital, New York, New York, United States
Weill Cornell Medical Center-New York Presbyterian Hospital, New York, New York, United States
Levine Cancer Institute-Albermarle, Albemarle, North Carolina, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Levine Cancer Institute-Pineville, Charlotte, North Carolina, United States
Levine Cancer Institute-Southpark, Charlotte, North Carolina, United States
Levine Cancer Institute-University, Charlotte, North Carolina, United States
Levine Cancer Institute-Ballantyne, Charlotte, North Carolina, United States
Levine Cancer Institute- Gaston, Gastonia, North Carolina, United States
Levine Cancer Institute-Lincolnton, Lincolnton, North Carolina, United States
Levine Cancer Institute-Monroe, Monroe, North Carolina, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Parkway Surgery Center, Myrtle Beach, South Carolina, United States
Levine Cancer Institute-Rock Hill, Rock Hill, South Carolina, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center, Tyler, Texas, United States
Virginia Oncology Associates, Hampton, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Swedish Cancer Institute Edmonds Campus, Edmonds, Washington, United States
Swedish Cancer Institute Issaquah Campus, Issaquah, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
Swedish Medical Center, Seattle, Washington, United States
Froedtert Hospital/Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Medical Imaging St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
St Vincent's Hospital Sydney, The Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia
PRP Diagnostic Imaging, Westmead, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Icon Cancer Care Wesley, Auchenflower, Queensland, Australia
Liz Plummer Cancer Care Center, Cairns, Queensland, Australia
Icon Cancer Care Chermside, Chermside, Queensland, Australia
Icon Cancer Care South Brisbane, South Brisbane, Queensland, Australia
Icon Cancer Care, South Brisbane, Queensland, Australia
Intergrated Clinical Oncology Network (ICON), South Brisbane, Queensland, Australia
Icon Cancer Care Southport, Southport, Queensland, Australia
Eastern Clinical Research Unit, Box Hill, Victoria, Australia
Eastern Health Pathology Service, Box Hill, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Peninsula Health, Frankston, Victoria, Australia
Olivia Newton John Cancer Wellness & Research Centre Austin Health, Heidelberg, Victoria, Australia
Ordensklinikum Linz, Barmherzige Schwestern, Linz, Upper Austria, Austria
Vinzenz Pathologieverbund, Linz, Upper Austria, Austria
Ordensklinikum Linz GmbH, Elisabethinen, Linz, Upper Austria, Austria
Paracelsus Medical University, SALK, Salzburg, , Austria
Isotopix-Ambulatorium fur Nuklearmedizin, Vienna, , Austria
Medical University of Vienna, Vienna, , Austria
Medizinische Universitat Wien, Vienna, , Austria
Diagnosezentrum Meidling, Vienna, , Austria
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Algemeen Ziekenhuis Sint-Lucas, Gent, , Belgium
UZ Leuven, Campus Gasthuisberg, Leuven, , Belgium
Hospital de Caridade de Ijui, Ijui, RIO Grande DO SUL, Brazil
Hospital de Clinicas de Porto Alegre-HCPA, Porto Alegre, RS, Brazil
Fundacao Pio XII-Hospital de Cancer de Barretos, Barretos, SAO Paulo, Brazil
Fundacao Doutor Amaral Carvalho, Jau, SAO Paulo, Brazil
ICO-Site Paul Papin, Angers Cedex 02, , France
CHRUBesangon-H6pital Jean Minjoz, Besancon, , France
Institut Bergonie, Service d'Oncologie, Bordeaux cedex, , France
Centre Hospitalier Departemental Les Oudairies, La Roche sur Yon, , France
Clinique Victor Hugo-Centre Jean Bernard, Le Mans Cedex 02, , France
Institut de Cancerologie Strasbourg Europe, Strasbourg, , France
Hopital Foch Service Oncologie, Suresnes Cedex, , France
Institut Gustave Roussy, VILLEJUIF cedex, , France
Universitaetsklinikum Essen, Essen, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Medizinische Fakultat Mannheim der Universitat Heidelberg, Mannheim, , Germany
Universitatsklinikum Munster, Munster, , Germany
Studienpraxis Urologie, Nuertingen, , Germany
Universitatsklinikum Tubingen, Tubingen, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Orszagos Onkologiai Intezet, "C" Belgyogyaszati-Onkologiai es Klinikai Farmakogogiai Osztaly, Budapest, , Hungary
Debreceni Egyetem, Debrecen, , Hungary
Szabolcs- Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz, Nyiregyhaza, , Hungary
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forli - Cesena, Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, Rome, Italy
Azienda Ospedaliero-Universitaria S. Luigi Gonzaga-SCDU Oncologia Medica, Orbassano, Torino/piemonte, Italy
AULSS3 Serenissima - Ospedale dell'Angelo - Oncologia Medica, Mestre, Venezia, Italy
Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona), Cremona, , Italy
SD Oncologia Clinica Sperimentale di Uro-Ginecologia, Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1, Padova, , Italy
Azienda Ospedaliero Universitari di Parma - U.O. Oncologia Medica, Parma, , Italy
Azienda Ospedaliero Universitaria di Parma - U.O. Oncologia Medica, Parma, , Italy
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino, Torino, , Italy
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Radboud UMC, Nijmegen, THE Netherlands, Netherlands
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza, Brzozow, , Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Kielce, , Poland
Hospital Virgen de la Victoria, Malaga, Malga, Spain
Clinica Universidad de Navarra-Oncology Service, Pamplona, Navarra, Spain
Hospital General Vall D'Hebron-Oncology Service, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitario Quironsalud Madrid-Oncology Service, Madrid, , Spain
Instituto Valenciano de Oncologia (IVO-FINCIVO), Valencia, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Mount Vernon Hospital, Northwood, Middlesex, United Kingdom
The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust , Sycamore House, Sutton, Surrey, United Kingdom
Addenbrookes Hospital, Cambridge, , United Kingdom
Name: Pfizer Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR