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

• ClinicalTrials.gov Identifier: NCT03148795
• Recruitment Status: Completed
• First Posted: May 11, 2017
• Results First Posted: September 8, 2021
• Last Update Posted: May 10, 2023
• Sponsor: Pfizer
• Collaborator: Medivation, Inc.
• Information provided by (Responsible Party): Pfizer

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Talazoparib	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 128 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: July 4, 2017
• Actual Primary Completion Date: September 4, 2020
• Actual Study Completion Date: March 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Talazoparib; Talazoparib 1 mg daily	Drug: Talazoparib; 1 mg daily; Other Name: MDV3800

Outcome Measures

Primary Outcome Measures :

1. Best Objective Response Rate (ORR) [ Time Frame: From first dose of study drug to best overall soft tissue response CR or PR (maximum duration of 25 months) ]
   Best ORR was defined as the percentage of participants with best overall soft tissue response of complete response (CR) or partial response (PR) as per RECIST1.1 by an independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline sum diameters.

Secondary Outcome Measures :

1. Time to Objective Response [ Time Frame: From first dose of study drug to first objective response (maximum duration of 25 months) ]
   Time to objective response was defined as the time from first dose of talazoparib to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per prostate cancer working Group 3 (PCWG3). Soft tissue response is defined as a best overall response of CR or PR per RECIST 1.1 by independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
2. Duration of Response (DOR) [ Time Frame: From the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first (maximum duration of 25 months) ]
   DOR was defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) per RECIST 1.1 and no evidence of confirmed bone disease progression per PCWG3 to the date of first objective evidence of radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
3. Percentage of Participants With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percent (%) [ Time Frame: Approximately 56 months ]
   Analysis is not final for this outcome measure at PCD, complete data will be posted at study completion date (SCD).
4. Percentage of Participants With Circulating Tumor Cell (CTC) Count Greater Than or Equal to (>=) 5 Circulating Tumor Cell (CTC) Per 7.5 Milliliter (mL) of Blood at Baseline Decreasing to Less Than (<) 5 CTC of Blood Any Time on Study [ Time Frame: Approximately 56 months ]
   Analysis is not final for this outcome measure at PCD, complete data will be posted at SCD.
5. Percentage of Participants With Circulating Tumor Cell (CTC) Count >=1 CTC Per 7.5 mL of Blood at Baseline Decreasing to Null CTC of Blood Any Time on Study [ Time Frame: Approximately 56 months ]
   Analysis is not final for this outcome measure at PCD, complete data will be posted at SCD.
6. Percentage of Participants With Circulating Tumor Cell (CTC) Count <5 CTC Per 7.5 mL of Blood at Baseline Increased Any Time on Study [ Time Frame: Approximately 56 months ]
   Analysis is not final for this outcome measure at PCD, complete data will be posted at SCD.
7. Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: Approximately 56 months ]
   Time to PSA progression was defined as the time from first dose of study treatment to the date of PSA progression, which was subsequently confirmed. Analysis is not final for this outcome measure at PCD, complete data will be posted at SCD.
8. Radiographic Progression-Free Survival (PFS) [ Time Frame: From date of first dose of study drug to first objective evidence of radiographic progression or death without documented radiographic progression, whichever occurs first (maximum duration of 25 months) ]
   Radiographic PFS was defined as the time from date of first dose of talazoparib to first objective evidence of radiographic progression as assessed in soft tissue per modified RECIST 1.1 or confirmed progression in bone per PCWG3 guidelines by independent central review or death without documented radiographic progression, whichever occurs first.
9. Overall Survival (OS) [ Time Frame: Approximately 56 months ]
   OS was defined as the time from the first dose of study treatment to death due to any cause. For participants who were alive, OS was censored at the last contact. Analysis is not final for this outcome measure at PCD, complete data will be posted at SCD.
10. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 28 days after last dose of study drug (approximately up to 26 months) ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
11. Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events [ Time Frame: Baseline up to 28 days after last dose of study drug (approximately up to 26 months) ]
    Treatment discontinuation was defined as permanent cessation of study drug treatment administration.
12. Number of Participants With Clinically Significant Abnormalities in Vital Signs [ Time Frame: Baseline up to 28 days after last dose of study drug (approximately up to 26 months) ]
    Vital sign abnormalities criteria included: 1) Systolic blood pressure (SBP) in millimeters of mercury (mmHg): absolute result greater than (>) 180 mmHg and increase from baseline greater than or equal to (>=) 40 mmHg or absolute result < 90 mmHg and decrease from baseline > 30 mmHg; 2) Diastolic blood pressure (DBP) (mmHg): absolute result > 110 mmHg and increase from baseline >= 30 mmHg or absolute result < 50 mmHg and decrease from baseline > 20 mmHg or >= 20 mmHg increase from baseline; 3) Heart rate in beats per minutes (bpm): absolute result < 50 bpm and decrease from baseline > 20 bpm or absolute result > 120 bpm and increase from baseline > 30 bpm; Weight in kilogram: > 10% decrease from baseline.
13. Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline [ Time Frame: Baseline up to 28 days after last dose of study drug (approximately up to 26 months) ]
    Hematology parameters included anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
14. Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline [ Time Frame: Baseline up to 28 days after last dose of study drug (approximately up to 26 months) ]
    Chemistry parameters:alanine aminotransferase increased(inc), alkaline phosphatase inc, aspartate aminotransferase inc, blood bilirubin inc, chronic kidney disease, creatinine inc, gamma-glutamyl transferase (GGT) inc, hypercalcemia, hypercalcemia, hyperkalemia, hypermagnesemia, hypermagnesemia, hypermagnesemia, hypocalcemia, hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia and hypophosphatemia. Severity was graded as G1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G2:moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G3:severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; G4:life-threatening consequence, urgent intervention indicated; G5: death related to AEs.
15. Number of Participants With Dose Modification [ Time Frame: Baseline up to 28 days after last dose of study drug (approximately up to 26 months) ]
    Number of participants with dose modification due to adverse events was reported.
16. Time to Deterioration in Pain Symptom Scores [ Time Frame: Approximately 56 months ]
    Time to deterioration in pain symptom scores was assessed by brief pain inventory short form (BPI-SF). Analysis is not final for this outcome measure at PCD, complete data will be posted at SCD.
17. Change From Baseline in Participant Reported Pain Scores Per BPI-SF Till End of the Study [ Time Frame: Approximately 56 months ]
    BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-SF are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Analysis is not final for this outcome measure at PCD, complete data will be posted at SCD.
18. Change From Baseline in Patient-Reported Health-Related Quality of Life as Assessed by European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Scores Till End of the Study [ Time Frame: Approximately 56 months ]
    The EQ-5D-5L consists of two sections, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression with five response levels for each dimension: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable). Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction. Analysis is not final for this outcome measure at PCD, complete data will be posted at SCD.
19. Pre-dose Plasma Concentration (Ctrough) of Talazoparib [ Time Frame: Pre-dose at Week 1, 5, 9 and 13 ]
    Ctrough was defined as pre-dose plasma concentration during dosing and observed directly from data.
20. Post-dose Plasma Concentration (Ctrough) of Talazoparib [ Time Frame: 2 hours post-dose at Week 1 and 5 ]
    Plasma concentration was measured 2 hours after dosing and observed directly from data.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. At least 18 years of age.
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without signet cell, or small cell features.
3. Patients must have measurable soft tissue disease per RECIST 1.1
4. 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.
5. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
6. Serum testosterone ≤ 1.73 nmol/L (50 ng/dL) at screening.
7. Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical castration).

8. 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.
9. Metastatic disease.
10. 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.
11. 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.
12. Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.
13. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
14. Estimated life expectancy of ≥ 6 months as assessed by the investigator.
15. Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.
16. 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.
17. Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug.
18. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

1. 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.
2. 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.
3. 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
4. Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
5. Major surgery within 2 weeks before day 1.
6. Clinically significant cardiovascular disease.
7. Significant renal, hepatic, or bone marrow organ dysfunction.
8. Known or suspected brain metastasis or active leptomeningeal disease.
9. Symptomatic or impending spinal cord compression or cauda equina syndrome.
10. Prior diagnosis of myelodysplastic syndrome or acute myeloid leukemia
11. 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.
12. Gastrointestinal disorder affecting absorption.
13. 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).
14. 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.
15. 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.
16. 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.

Contacts and Locations

Locations

United States, Arizona

Arizona Oncology Associates

Tempe, Arizona, United States, 85284

United States, California

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States, 91010

City of Hope-Antelope Valley

Lancaster, California, United States, 93534

UC Irvine Health Investigational Drug Pharmacy

Orange, California, United States, 92868

University of California, Irvine Medical Center

Orange, California, United States, 92868

Medical Oncology Associates-SD

San Diego, California, United States, 92123

Sharp Outpatient Infusion Therapy Center

San Diego, California, United States, 92123

Sharp Rees-Stealy

San Diego, California, United States, 92123

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30322

The Emory Clinic

Atlanta, Georgia, United States, 30322

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

Piedmont Cancer Institute, PC

Fayetteville, Georgia, United States, 30214

Piedmont Cancer Institute, PC

Newnan, Georgia, United States, 30265

United States, Missouri

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States, 63141

Barnes-Jewish Hospital

Saint Louis, Missouri, United States, 63110

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

Siteman Cancer Center - South County

Saint Louis, Missouri, United States, 63129

Christian Hospital North East

Saint Louis, Missouri, United States, 63136

Siteman Cancer Center - St. Peters

Saint Peters, Missouri, United States, 63376

United States, New York

Weill Cornell Medical Center - New York Presbyterian Hospital

New York, New York, United States, 10021

Weill Cornell Medical Center-New York Presbyterian Hospital

New York, New York, United States, 10021

United States, North Carolina

Levine Cancer Institute-Albermarle

Albemarle, North Carolina, United States, 28001

Carolinas Medical Center

Charlotte, North Carolina, United States, 28203

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Levine Cancer Institute-Pineville

Charlotte, North Carolina, United States, 28210

Levine Cancer Institute-Southpark

Charlotte, North Carolina, United States, 28211

Levine Cancer Institute-University

Charlotte, North Carolina, United States, 28262

Levine Cancer Institute-Ballantyne

Charlotte, North Carolina, United States, 28277

Levine Cancer Institute- Gaston

Gastonia, North Carolina, United States, 28054

Levine Cancer Institute-Lincolnton

Lincolnton, North Carolina, United States, 28092

Levine Cancer Institute-Monroe

Monroe, North Carolina, United States, 28112

United States, South Carolina

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

Parkway Surgery Center

Myrtle Beach, South Carolina, United States, 29572

Levine Cancer Institute-Rock Hill

Rock Hill, South Carolina, United States, 29732

United States, Texas

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center

Tyler, Texas, United States, 75701

United States, Virginia

Virginia Oncology Associates

Hampton, Virginia, United States, 23666

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

United States, Washington

Swedish Cancer Institute Edmonds Campus

Edmonds, Washington, United States, 98026

Swedish Cancer Institute Issaquah Campus

Issaquah, Washington, United States, 98029

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Swedish Medical Center

Seattle, Washington, United States, 98122

United States, Wisconsin

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Australia, New South Wales

Medical Imaging St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

St Vincent's Hospital Sydney, The Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia, 2010

PRP Diagnostic Imaging

Westmead, New South Wales, Australia, 2145

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Australia, Queensland

Icon Cancer Care Wesley

Auchenflower, Queensland, Australia, 4066

Liz Plummer Cancer Care Center

Cairns, Queensland, Australia, 4870

Icon Cancer Care Chermside

Chermside, Queensland, Australia, 4032

Icon Cancer Care South Brisbane

South Brisbane, Queensland, Australia, 4101

Icon Cancer Care

South Brisbane, Queensland, Australia, 4101

Intergrated Clinical Oncology Network (ICON)

South Brisbane, Queensland, Australia, 4101

Icon Cancer Care Southport

Southport, Queensland, Australia, 4215

Australia, Victoria

Eastern Clinical Research Unit

Box Hill, Victoria, Australia, 3128

Eastern Health Pathology Service

Box Hill, Victoria, Australia, 3128

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Peninsula Health

Frankston, Victoria, Australia, 3199

Olivia Newton John Cancer Wellness & Research Centre Austin Health

Heidelberg, Victoria, Australia, 3084

Austria

Ordensklinikum Linz, Barmherzige Schwestern

Linz, Upper Austria, Austria, 4010

Vinzenz Pathologieverbund

Linz, Upper Austria, Austria, 4010

Ordensklinikum Linz GmbH, Elisabethinen

Linz, Upper Austria, Austria, 4020

Paracelsus Medical University, SALK

Salzburg, Austria, 5020

Isotopix-Ambulatorium fur Nuklearmedizin

Vienna, Austria, 1090

Medical University of Vienna

Vienna, Austria, 1090

Medizinische Universitat Wien

Vienna, Austria, 1090

Diagnosezentrum Meidling

Vienna, Austria, 1120

Belgium

Cliniques Universitaires Saint-Luc

Bruxelles, Belgium, 1200

Algemeen Ziekenhuis Sint-Lucas

Gent, Belgium, 9000

UZ Leuven, Campus Gasthuisberg

Leuven, Belgium, 3000

Brazil

Hospital de Caridade de Ijui

Ijui, RIO Grande DO SUL, Brazil, 98700-000

Hospital de Clinicas de Porto Alegre-HCPA

Porto Alegre, RS, Brazil, 90035-903

Fundacao Pio XII-Hospital de Cancer de Barretos

Barretos, SAO Paulo, Brazil, 14784-400

Fundacao Doutor Amaral Carvalho

Jau, SAO Paulo, Brazil, 17210-120

France

ICO-Site Paul Papin

Angers Cedex 02, France, 49055

CHRUBesangon-H6pital Jean Minjoz

Besancon, France, 25030

Institut Bergonie, Service d'Oncologie

Bordeaux cedex, France, 33076

Centre Hospitalier Departemental Les Oudairies

La Roche sur Yon, France, 85925

Clinique Victor Hugo-Centre Jean Bernard

Le Mans Cedex 02, France, 72015

Institut de Cancerologie Strasbourg Europe

Strasbourg, France, 67200

Hopital Foch Service Oncologie

Suresnes Cedex, France, 92151

Institut Gustave Roussy

VILLEJUIF cedex, France, 94805

Germany

Universitaetsklinikum Essen

Essen, Germany, 45122

Medizinische Hochschule Hannover

Hannover, Germany, 30625

Medizinische Fakultat Mannheim der Universitat Heidelberg

Mannheim, Germany, 68167

Universitatsklinikum Munster

Munster, Germany, 48149

Studienpraxis Urologie

Nuertingen, Germany, 72622

Universitatsklinikum Tubingen

Tubingen, Germany, 72076

Universitaetsklinikum Wuerzburg

Wuerzburg, Germany, 97080

Hungary

Semmelweis Egyetem

Budapest, Hungary, 1082

Orszagos Onkologiai Intezet, "C" Belgyogyaszati-Onkologiai es Klinikai Farmakogogiai Osztaly

Budapest, Hungary, 1122

Debreceni Egyetem

Debrecen, Hungary, 4032

Szabolcs- Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz

Nyiregyhaza, Hungary, 4400

Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Forli - Cesena, Italy, 47014

Azienda Ospedaliera San Camillo Forlanini

Roma, Rome, Italy, 00152

Azienda Ospedaliero-Universitaria S. Luigi Gonzaga-SCDU Oncologia Medica

Orbassano, Torino/piemonte, Italy, 10043

AULSS3 Serenissima - Ospedale dell'Angelo - Oncologia Medica

Mestre, Venezia, Italy, 30174

Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)

Cremona, Italy, 26100

SD Oncologia Clinica Sperimentale di Uro-Ginecologia

Napoli, Italy, 80131

IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1

Padova, Italy, 35128

Azienda Ospedaliero Universitari di Parma - U.O. Oncologia Medica

Parma, Italy, 43126

Azienda Ospedaliero Universitaria di Parma - U.O. Oncologia Medica

Parma, Italy, 43126

Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy, 10126

Korea, Republic of

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620

Pusan National University Hospital

Busan, Korea, Republic of, 49241

Kyungpook National University Chilgok Hospital

Daegu, Korea, Republic of, 41404

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Netherlands

Radboud UMC

Nijmegen, THE Netherlands, Netherlands, 6525 GA

Poland

Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

Brzozow, Poland, 36-200

Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Kielce, Poland, 25-734

Spain

Hospital Virgen de la Victoria

Malaga, Malga, Spain, 29010

Clinica Universidad de Navarra-Oncology Service

Pamplona, Navarra, Spain, 31008

Hospital General Vall D'Hebron-Oncology Service

Barcelona, Spain, 08035

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital Universitario Quironsalud Madrid-Oncology Service

Madrid, Spain, 28223

Instituto Valenciano de Oncologia (IVO-FINCIVO)

Valencia, Spain, 46009

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

United Kingdom

Mount Vernon Hospital

Northwood, Middlesex, United Kingdom, HA6 2RN

The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust , Sycamore House

Sutton, Surrey, United Kingdom, SM2 5PT

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Sponsors and Collaborators

Pfizer

Medivation, Inc.

Investigators

• Study Director: Pfizer Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] November 15, 2018

Statistical Analysis Plan  [PDF] October 1, 2020

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mehra N, Fizazi K, de Bono JS, Barthelemy P, Dorff T, Stirling A, Machiels JP, Bimbatti D, Kilari D, Dumez H, Buttigliero C, van Oort IM, Castro E, Chen HC, Di Santo N, DeAnnuntis L, Healy CG, Scagliotti GV. Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. Oncologist. 2022 Oct 1;27(10):e783-e795. doi: 10.1093/oncolo/oyac172.

de Bono JS, Mehra N, Scagliotti GV, Castro E, Dorff T, Stirling A, Stenzl A, Fleming MT, Higano CS, Saad F, Buttigliero C, van Oort IM, Laird AD, Mata M, Chen HC, Healy CG, Czibere A, Fizazi K. Talazoparib monotherapy in metastatic castration-resistant prostate cancer with DNA repair alterations (TALAPRO-1): an open-label, phase 2 trial. Lancet Oncol. 2021 Sep;22(9):1250-1264. doi: 10.1016/S1470-2045(21)00376-4. Epub 2021 Aug 10. Erratum In: Lancet Oncol. 2022 May;23(5):e207. Lancet Oncol. 2022 Jun;23(6):e249.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03148795
• Other Study ID Numbers: MDV3800-06; C3441006 ( Other Identifier: Alias Study Number ); 2016-002036-32 ( EudraCT Number )
• First Posted: May 11, 2017
• Results First Posted: September 8, 2021
• Last Update Posted: May 10, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Talazoparib; Poly(ADP-ribose) Polymerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents