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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03395197




Registration number
NCT03395197
Ethics application status
Date submitted
21/11/2017
Date registered
10/01/2018

Titles & IDs
Public title
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
Scientific title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Secondary ID [1] 0 0
2017-003295-31
Secondary ID [2] 0 0
C3441021
Universal Trial Number (UTN)
Trial acronym
TALAPRO-2
Linked study record

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

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

Experimental: Combination arm - Talazoparib plus enzalutamide

Active comparator: Monotherapy arm - Ezalutamide plus placebo


Treatment: Drugs: Talazoparib with enzalutamide
Talazoparib 0.5 mg/day plus enzalutamide 160mg/day

Treatment: Drugs: Placebo with enzalutamide
Placebo plus enzalutamide 160 mg/day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Timepoint [1] 0 0
Post dose on Day 1 up to Day 66 in Part 1
Primary outcome [2] 0 0
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Timepoint [2] 0 0
Post dose on Day 1 up to Day 66 in Part 1
Primary outcome [3] 0 0
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Timepoint [3] 0 0
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Primary outcome [4] 0 0
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
Timepoint [4] 0 0
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Primary outcome [5] 0 0
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Timepoint [5] 0 0
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Primary outcome [6] 0 0
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Timepoint [6] 0 0
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Primary outcome [7] 0 0
Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
Timepoint [7] 0 0
From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
Primary outcome [8] 0 0
BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2
Timepoint [8] 0 0
From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed adenocarcinoma of the prostate without small 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
1054
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [4] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [5] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [6] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [8] 0 0
ICON Cancer Centre Chermside - Chermside
Recruitment hospital [9] 0 0
ICON Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [10] 0 0
Integrated Clinical Oncology Network Pty Ltd (ICON) - South Brisbane
Recruitment hospital [11] 0 0
ICON Cancer Centre Southport - Southport
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [13] 0 0
Peter MacCallum Cancer Centre - North Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
4032 - Chermside
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
3000 - Melbourne
Recruitment postcode(s) [10] 0 0
3051 - North Melbourne
Recruitment outside Australia
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Alaska
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Arizona
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Colorado
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Florida
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Santa FE
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Caba
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Cordoba
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LA ROCHE SUR YON cedex 9
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VILLEJUIF cedex
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Israel
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BO
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Italy
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CR
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Italy
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FC
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Italy
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TN
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Italy
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TO
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Italy
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Napoli
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Aichi
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Ishikawa
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Kumamoto
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Tokushima
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Yamagata
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Korea, Republic of
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Gyeonggi-do
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Busan
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Daegu
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Seoul
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BAY OF Plenty
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Canterbury
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New Zealand
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Waikato
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New Zealand
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Auckland
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Norway
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Gralum
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Norway
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Lorenskog
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Norway
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Oslo
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Norway
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Trondheim
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Brzozow
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Poland
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Gdynia
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Konin
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Otwock
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Poland
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Warszawa
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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South Africa
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Eastern CAPE
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South Africa
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Gauteng
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South Africa
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Western CAPE
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South Africa
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Johannesburg
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Spain
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A Coruna
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Murcia
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Spain
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Madrid
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Sweden
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Goteborg
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Sweden
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Stockholm
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Sweden
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Umeå
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United Kingdom
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Devon
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United Kingdom
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Oxfordshire
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United Kingdom
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Scotland
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Wirral
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Cornwall
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Glasgow
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Liverpool
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London
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United Kingdom
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Oxford

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
Astellas Pharma Inc
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Ethics approval
Ethics application status

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

Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for public queries
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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/NCT03395197