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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02184195




Registration number
NCT02184195
Ethics application status
Date submitted
6/06/2014
Date registered
9/07/2014

Titles & IDs
Public title
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Scientific title
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
Secondary ID [1] 0 0
2014-001589-85
Secondary ID [2] 0 0
D081FC00001
Universal Trial Number (UTN)
Trial acronym
POLO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Germline BRCA1/2 Mutations and 0 0
Metastatic Adenocarcinoma of the Pancreas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

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

Experimental: Olaparib - Olaparib tablets po. 300 mg twice daily

Placebo comparator: Placebo - Placebo tablets twice daily


Treatment: Drugs: Olaparib
Tablet -100mg

Treatment: Drugs: Olaparib
Tablet-150mg

Treatment: Drugs: Placebo
Match Olaparib 100mg placebo

Treatment: Drugs: Placebo
Match Olaparib 150mg placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Upto 4 years
Secondary outcome [2] 0 0
Time From Randomisation to Second Progression (PFS2)
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Time From Randomisation to Second Subsequent Therapy or Death (TSST)
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Time From Randomisation to First Subsequent Therapy or Death (TFST)
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time From Randomisation to Study Treatment Discontinuation or Death (TDT)
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1
Timepoint [7] 0 0
At 16 weeks
Secondary outcome [8] 0 0
Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
Timepoint [8] 0 0
From baseline up to 6 months
Secondary outcome [9] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [9] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
Key Inclusion Criteria

* Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment
* Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in this study.
* Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious
* Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16 weeks of continuous platinum treatment and have no evidence of progression based on investigator's opinion.
* Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and initiation of the platinum-based chemotherapy for metastatic pancreas cancer.

Major
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg, "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favour polymorphism" or "benign polymorphism" etc.)
* Progression of tumour between start of first line platinum based chemotherapy for metastatic pancreas cancer and randomisation.
* Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle

1 Day 1 is not permitted.
* Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
* Any previous treatment with a PARP inhibitor, including Olaparib

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2023
Sample size
Target
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Campbelltown
Recruitment hospital [2] 0 0
Research Site - Randwick
Recruitment hospital [3] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
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
Colorado
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United States of America
State/province [4] 0 0
Connecticut
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United States of America
State/province [5] 0 0
Florida
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Belgium
State/province [15] 0 0
Antwerpen
Country [16] 0 0
Belgium
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Brussel
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
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Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
Toronto
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France
State/province [21] 0 0
Amiens
Country [22] 0 0
France
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Besançon
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France
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Bordeaux
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France
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Brest Cedex
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France
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Clichy Cedex
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France
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La Roche sur Yon
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France
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Lille
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France
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Lyon Cedex 03
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France
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Nice
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France
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Paris CEDEX 14
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France
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Paris
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France
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Poitiers
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France
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STRASBOURG Cedex
Country [34] 0 0
France
State/province [34] 0 0
Toulouse
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France
State/province [35] 0 0
Villejuif
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Germany
State/province [36] 0 0
Berlin
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Frankfurt am Main
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Leipzig
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Germany
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München
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Germany
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Schweinfurt
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Germany
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Ulm
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Holon
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Israel
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Nahariya
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Zefir
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Italy
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Bologna
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Italy
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Milano
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Italy
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Padova
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Italy
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Parma
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Italy
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Pescara
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Italy
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Roma
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Italy
State/province [62] 0 0
San Giovanni Rotondo
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Italy
State/province [63] 0 0
Verona
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Korea, Republic of
State/province [64] 0 0
Seongnam-si
Country [65] 0 0
Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Spain
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Barcelona
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Spain
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Girona
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Spain
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L'Hospitalet de Llobregat
Country [70] 0 0
Spain
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Madrid
Country [71] 0 0
Spain
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Málaga
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Spain
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Pamplona
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Spain
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Sabadell
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Spain
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Santiago de Compostela
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Spain
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Valencia
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Spain
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Zaragoza
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
State/province [83] 0 0
Nottingham
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Myriad Genetic Laboratories, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Merck Sharp & Dohme LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT02184195