Prostate Cancer Clinical Trial

A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age.
Histologically or cytologically confirmed adenocarcinoma of the prostate without signet cell, or small cell features.
Patients must have measurable soft tissue disease per RECIST 1.1
DNA damage repair deficiency as assessed centrally by a gene mutation biomarker panel (testing of de novo or archival tumor tissue (via central laboratory) or prior historical testing (with Sponsor approval) using the Foundation Medicine, FoundationOne CDx™ NGS gene panel test.
Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
Serum testosterone ≤ 1.73 nmol/L (50 ng/dL) at screening.
Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical castration).

Progressive disease at study entry defined as 1 or more of the following 3 criteria:

A minimum of 3 rising PSA values with an interval of at least 1 week between determinations. The screening central laboratory PSA value must be ≥ 2 μg/L (2 ng/mL) if qualifying solely by PSA progression.
Soft tissue disease progression as defined by RECIST 1.1.
Bone disease progression defined by PCWG3 with 2 or more new metastatic lesions on bone scan.
Metastatic disease.
Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based regimen for metastatic (non castrate or castrate) prostate cancer. Patients may have received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.
Documented disease progression (either radiographic or biochemical) on at least 1 novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) for the treatment of metastatic CRPC, irrespective of prior NHT treatment for non castrate prostate cancer or nonmetastatic (M0) CRPC.
Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Estimated life expectancy of ≥ 6 months as assessed by the investigator.
Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.
Must use a condom when having sex from the time of the first dose of study drug through 4 months after last dose of study drug. A highly effective form of contraception must be used from the time of the first dose of study drug through 4 months after last dose of study drug 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.
Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

1. Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.
Prior treatment with a PARP inhibitor, cyclophosphamide, or mitoxantrone chemotherapy. Patients who discontinued prior platinum based chemotherapy <=6 months prior to screening or whose disease previously progressed on platinum based therapy at any time in the past are also excluded.
Treatment with any concurrent cytotoxic chemotherapy or investigational drug(s) within 4 weeks or 5 half lives of the drug (whichever is longer) before Day 1 and/or during study participation
Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
Major surgery within 2 weeks before day 1.
Clinically significant cardiovascular disease.
Significant renal, hepatic, or bone marrow organ dysfunction.
Known or suspected brain metastasis or active leptomeningeal disease.
Symptomatic or impending spinal cord compression or cauda equina syndrome.
Prior diagnosis of myelodysplastic syndrome or acute myeloid leukemia
History of another cancer within 3 years before enrollment with the exception of nonmelanoma skin cancers, or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
Gastrointestinal disorder affecting absorption.
Current or anticipated use within 7 days prior to first dose of study drug or anticipated use during the study of the following P gp inhibitors (amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, verapamil, and valspodar).
Any other acute or chronic medical or psychiatric condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of data, in the opinion of the investigator or sponsor, including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that 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.
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.
Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 4 months after the last dose of investigational product.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

128

Study ID:

NCT03148795

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 102 Locations for this study

See Locations Near You

Arizona Oncology Associates
Tempe Arizona, 85284, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte California, 91010, United States
City of Hope-Antelope Valley
Lancaster California, 93534, United States
UC Irvine Health Investigational Drug Pharmacy
Orange California, 92868, United States
University of California, Irvine Medical Center
Orange California, 92868, United States
Medical Oncology Associates-SD
San Diego California, 92123, United States
Sharp Outpatient Infusion Therapy Center
San Diego California, 92123, United States
Sharp Rees-Stealy
San Diego California, 92123, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
The Emory Clinic
Atlanta Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Piedmont Cancer Institute, PC
Fayetteville Georgia, 30214, United States
Piedmont Cancer Institute, PC
Newnan Georgia, 30265, United States
Siteman Cancer Center - West County
Creve Coeur Missouri, 63141, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Siteman Cancer Center - South County
Saint Louis Missouri, 63129, United States
Christian Hospital North East
Saint Louis Missouri, 63136, United States
Siteman Cancer Center - St. Peters
Saint Peters Missouri, 63376, United States
Weill Cornell Medical Center - New York Presbyterian Hospital
New York New York, 10021, United States
Weill Cornell Medical Center-New York Presbyterian Hospital
New York New York, 10021, United States
Levine Cancer Institute-Albermarle
Albemarle North Carolina, 28001, United States
Carolinas Medical Center
Charlotte North Carolina, 28203, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Levine Cancer Institute-Pineville
Charlotte North Carolina, 28210, United States
Levine Cancer Institute-Southpark
Charlotte North Carolina, 28211, United States
Levine Cancer Institute-University
Charlotte North Carolina, 28262, United States
Levine Cancer Institute-Ballantyne
Charlotte North Carolina, 28277, United States
Levine Cancer Institute- Gaston
Gastonia North Carolina, 28054, United States
Levine Cancer Institute-Lincolnton
Lincolnton North Carolina, 28092, United States
Levine Cancer Institute-Monroe
Monroe North Carolina, 28112, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Parkway Surgery Center
Myrtle Beach South Carolina, 29572, United States
Levine Cancer Institute-Rock Hill
Rock Hill South Carolina, 29732, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
Tyler Texas, 75701, United States
Virginia Oncology Associates
Hampton Virginia, 23666, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Swedish Cancer Institute Edmonds Campus
Edmonds Washington, 98026, United States
Swedish Cancer Institute Issaquah Campus
Issaquah Washington, 98029, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Swedish Medical Center
Seattle Washington, 98122, United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Medical Imaging St Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
St Vincent's Hospital Sydney, The Kinghorn Cancer Centre
Darlinghurst New South Wales, 2010, Australia
PRP Diagnostic Imaging
Westmead New South Wales, 2145, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Icon Cancer Care Wesley
Auchenflower Queensland, 4066, Australia
Liz Plummer Cancer Care Center
Cairns Queensland, 4870, Australia
Icon Cancer Care Chermside
Chermside Queensland, 4032, Australia
Icon Cancer Care South Brisbane
South Brisbane Queensland, 4101, Australia
Icon Cancer Care
South Brisbane Queensland, 4101, Australia
Intergrated Clinical Oncology Network (ICON)
South Brisbane Queensland, 4101, Australia
Icon Cancer Care Southport
Southport Queensland, 4215, Australia
Eastern Clinical Research Unit
Box Hill Victoria, 3128, Australia
Eastern Health Pathology Service
Box Hill Victoria, 3128, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
Peninsula Health
Frankston Victoria, 3199, Australia
Olivia Newton John Cancer Wellness & Research Centre Austin Health
Heidelberg Victoria, 3084, Australia
Ordensklinikum Linz, Barmherzige Schwestern
Linz Upper Austria, 4010, Austria
Vinzenz Pathologieverbund
Linz Upper Austria, 4010, Austria
Ordensklinikum Linz GmbH, Elisabethinen
Linz Upper Austria, 4020, Austria
Paracelsus Medical University, SALK
Salzburg , 5020, Austria
Isotopix-Ambulatorium fur Nuklearmedizin
Vienna , 1090, Austria
Medical University of Vienna
Vienna , 1090, Austria
Medizinische Universitat Wien
Vienna , 1090, Austria
Diagnosezentrum Meidling
Vienna , 1120, Austria
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium
Algemeen Ziekenhuis Sint-Lucas
Gent , 9000, Belgium
UZ Leuven, Campus Gasthuisberg
Leuven , 3000, Belgium
Hospital de Caridade de Ijui
Ijui RIO Grande DO SUL, 98700, Brazil
Hospital de Clinicas de Porto Alegre-HCPA
Porto Alegre RS, 90035, Brazil
Fundacao Pio XII-Hospital de Cancer de Barretos
Barretos SAO Paulo, 14784, Brazil
Fundacao Doutor Amaral Carvalho
Jau SAO Paulo, 17210, Brazil
ICO-Site Paul Papin
Angers Cedex 02 , 49055, France
CHRUBesangon-H6pital Jean Minjoz
Besancon , 25030, France
Institut Bergonie, Service d'Oncologie
Bordeaux cedex , 33076, France
Centre Hospitalier Departemental Les Oudairies
La Roche sur Yon , 85925, France
Clinique Victor Hugo-Centre Jean Bernard
Le Mans Cedex 02 , 72015, France
Institut de Cancerologie Strasbourg Europe
Strasbourg , 67200, France
Hopital Foch Service Oncologie
Suresnes Cedex , 92151, France
Institut Gustave Roussy
VILLEJUIF cedex , 94805, France
Universitaetsklinikum Essen
Essen , 45122, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Medizinische Fakultat Mannheim der Universitat Heidelberg
Mannheim , 68167, Germany
Universitatsklinikum Munster
Munster , 48149, Germany
Studienpraxis Urologie
Nuertingen , 72622, Germany
Universitatsklinikum Tubingen
Tubingen , 72076, Germany
Universitaetsklinikum Wuerzburg
Wuerzburg , 97080, Germany
Semmelweis Egyetem
Budapest , 1082, Hungary
Orszagos Onkologiai Intezet, "C" Belgyogyaszati-Onkologiai es Klinikai Farmakogogiai Osztaly
Budapest , 1122, Hungary
Debreceni Egyetem
Debrecen , 4032, Hungary
Szabolcs- Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz
Nyiregyhaza , 4400, Hungary
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola Forli - Cesena, 47014, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma Rome, 00152, Italy
Azienda Ospedaliero-Universitaria S. Luigi Gonzaga-SCDU Oncologia Medica
Orbassano Torino/piemonte, 10043, Italy
AULSS3 Serenissima - Ospedale dell'Angelo - Oncologia Medica
Mestre Venezia, 30174, Italy
Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)
Cremona , 26100, Italy
SD Oncologia Clinica Sperimentale di Uro-Ginecologia
Napoli , 80131, Italy
IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
Padova , 35128, Italy
Azienda Ospedaliero Universitari di Parma - U.O. Oncologia Medica
Parma , 43126, Italy
Azienda Ospedaliero Universitaria di Parma - U.O. Oncologia Medica
Parma , 43126, Italy
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Radboud UMC
Nijmegen THE Netherlands, 6525 , Netherlands
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozow , 36-20, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Kielce , 25-73, Poland
Hospital Virgen de la Victoria
Malaga Malga, 29010, Spain
Clinica Universidad de Navarra-Oncology Service
Pamplona Navarra, 31008, Spain
Hospital General Vall D'Hebron-Oncology Service
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitario Quironsalud Madrid-Oncology Service
Madrid , 28223, Spain
Instituto Valenciano de Oncologia (IVO-FINCIVO)
Valencia , 46009, Spain
Hospital Universitari i Politecnic La Fe
Valencia , 46026, Spain
Mount Vernon Hospital
Northwood Middlesex, HA6 2, United Kingdom
The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust , Sycamore House
Sutton Surrey, SM2 5, United Kingdom
Addenbrookes Hospital
Cambridge , CB2 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

128

Study ID:

NCT03148795

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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