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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03148795




Registration number
NCT03148795
Ethics application status
Date submitted
9/05/2017
Date registered
11/05/2017

Titles & IDs
Public title
A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
Scientific 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)
Secondary ID [1] 0 0
C3441006
Secondary ID [2] 0 0
MDV3800-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Talazoparib

Experimental: Talazoparib - Talazoparib 1 mg daily


Treatment: Drugs: Talazoparib
1 mg daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best Objective Response Rate (ORR)
Timepoint [1] 0 0
From first dose of study drug to best overall soft tissue response CR or PR (maximum duration of 25 months)
Secondary outcome [1] 0 0
Time to Objective Response
Timepoint [1] 0 0
From first dose of study drug to first objective response (maximum duration of 25 months)
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Percentage of Participants With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percentage (%)
Timepoint [3] 0 0
From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)
Secondary outcome [4] 0 0
Percentage of Participants With Conversion of Circulating Tumor Cell (CTC) Count
Timepoint [4] 0 0
Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months
Secondary outcome [5] 0 0
Percentage of Participants With a Null CTC Count
Timepoint [5] 0 0
Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months
Secondary outcome [6] 0 0
Percentage of Participants With Baseline CTC Count <5 CTC Showed Increased CTC Counts at Any Time on Study
Timepoint [6] 0 0
Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months
Secondary outcome [7] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [7] 0 0
From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)
Secondary outcome [8] 0 0
Radiographic Progression-Free Survival (PFS)
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
From first dose of study treatment up to death due to any cause during study or date of last contact (approximately 36 months)
Secondary outcome [10] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [10] 0 0
First dose of study drug up to 28 days after last dose of study drug (study treatment was approximately for 36 months, safety follow up to approximately 37 months)
Secondary outcome [11] 0 0
Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events
Timepoint [11] 0 0
During study treatment (approximately up to 36 months)
Secondary outcome [12] 0 0
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Timepoint [12] 0 0
During study treatment (approximately up to 36 months)
Secondary outcome [13] 0 0
Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline
Timepoint [13] 0 0
During study treatment (approximately up to 36 months)
Secondary outcome [14] 0 0
Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline
Timepoint [14] 0 0
During study treatment (approximately up to 36 months)
Secondary outcome [15] 0 0
Number of Participants With Dose Modification
Timepoint [15] 0 0
During study treatment (approximately up to 36 months)
Secondary outcome [16] 0 0
Time to Deterioration in Pain Symptom Scores
Timepoint [16] 0 0
Baseline till final analysis of the outcome measure, up to maximum duration of 25 months
Secondary outcome [17] 0 0
Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3
Timepoint [17] 0 0
Baseline, Week 1, 3, 5, 7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
Secondary outcome [18] 0 0
Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS)
Timepoint [18] 0 0
Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
Secondary outcome [19] 0 0
Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain
Timepoint [19] 0 0
Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
Secondary outcome [20] 0 0
Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain
Timepoint [20] 0 0
Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
Secondary outcome [21] 0 0
Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain
Timepoint [21] 0 0
Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
Secondary outcome [22] 0 0
Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain
Timepoint [22] 0 0
Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
Secondary outcome [23] 0 0
Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain
Timepoint [23] 0 0
Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
Secondary outcome [24] 0 0
Pre-dose Plasma Concentration (Ctrough) of Talazoparib
Timepoint [24] 0 0
Pre-dose at Week 1, 5, 9 and 13
Secondary outcome [25] 0 0
Post-dose Plasma Concentration (Ctrough) of Talazoparib
Timepoint [25] 0 0
2 hours post-dose at Week 1 and 5

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Medical Imaging St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney, The Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [3] 0 0
PRP Diagnostic Imaging - Westmead
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [6] 0 0
Liz Plummer Cancer Care Center - Cairns
Recruitment hospital [7] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [8] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [9] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [10] 0 0
Intergrated Clinical Oncology Network (ICON) - South Brisbane
Recruitment hospital [11] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [12] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [13] 0 0
Eastern Health Pathology Service - Box Hill
Recruitment hospital [14] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [15] 0 0
Peninsula Health - Frankston
Recruitment hospital [16] 0 0
Olivia Newton John Cancer Wellness & Research Centre Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3199 - Frankston
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Austria
State/province [12] 0 0
Upper Austria
Country [13] 0 0
Austria
State/province [13] 0 0
Salzburg
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Brazil
State/province [18] 0 0
RIO Grande DO SUL
Country [19] 0 0
Brazil
State/province [19] 0 0
RS
Country [20] 0 0
Brazil
State/province [20] 0 0
SAO Paulo
Country [21] 0 0
France
State/province [21] 0 0
Angers Cedex 02
Country [22] 0 0
France
State/province [22] 0 0
Besancon
Country [23] 0 0
France
State/province [23] 0 0
Bordeaux cedex
Country [24] 0 0
France
State/province [24] 0 0
La Roche sur Yon
Country [25] 0 0
France
State/province [25] 0 0
Le Mans Cedex 02
Country [26] 0 0
France
State/province [26] 0 0
Strasbourg
Country [27] 0 0
France
State/province [27] 0 0
Suresnes Cedex
Country [28] 0 0
France
State/province [28] 0 0
VILLEJUIF cedex
Country [29] 0 0
Germany
State/province [29] 0 0
Essen
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Mannheim
Country [32] 0 0
Germany
State/province [32] 0 0
Munster
Country [33] 0 0
Germany
State/province [33] 0 0
Nuertingen
Country [34] 0 0
Germany
State/province [34] 0 0
Tubingen
Country [35] 0 0
Germany
State/province [35] 0 0
Wuerzburg
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Debrecen
Country [38] 0 0
Hungary
State/province [38] 0 0
Nyiregyhaza
Country [39] 0 0
Italy
State/province [39] 0 0
Forli - Cesena
Country [40] 0 0
Italy
State/province [40] 0 0
Rome
Country [41] 0 0
Italy
State/province [41] 0 0
Torino/piemonte
Country [42] 0 0
Italy
State/province [42] 0 0
Venezia
Country [43] 0 0
Italy
State/province [43] 0 0
Cremona
Country [44] 0 0
Italy
State/province [44] 0 0
Napoli
Country [45] 0 0
Italy
State/province [45] 0 0
Padova
Country [46] 0 0
Italy
State/province [46] 0 0
Parma
Country [47] 0 0
Italy
State/province [47] 0 0
Torino
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Gyeonggi-do
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Busan
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Daegu
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Seoul
Country [52] 0 0
Netherlands
State/province [52] 0 0
THE Netherlands
Country [53] 0 0
Poland
State/province [53] 0 0
Brzozow
Country [54] 0 0
Poland
State/province [54] 0 0
Kielce
Country [55] 0 0
Spain
State/province [55] 0 0
Malga
Country [56] 0 0
Spain
State/province [56] 0 0
Navarra
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Middlesex
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Surrey
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medivation, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03148795