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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02369874




Registration number
NCT02369874
Ethics application status
Date submitted
18/02/2015
Date registered
24/02/2015

Titles & IDs
Public title
Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
Scientific title
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Secondary ID [1] 0 0
D4193C00002
Universal Trial Number (UTN)
Trial acronym
EAGLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEDI4736
Treatment: Drugs - MEDI4736 + Tremelimumab
Treatment: Drugs - Standard of Care

Experimental: MEDI4736 - MEDI4736 monotherapy

Experimental: MEDI4736 + Tremelimumab - MEDI4736 + tremelimumab combination therapy

Active comparator: Standard of Care - Standard of Care


Treatment: Drugs: MEDI4736
MEDI4736 Monotherapy

Treatment: Drugs: MEDI4736 + Tremelimumab
MEDI4736 + Tremelimumab combination therapy

Treatment: Drugs: Standard of Care
Standard of Care
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [1] 0 0
Overall Survival (OS) in PD-L1 Negative Participants
Timepoint [1] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [2] 0 0
Overall Survival (OS) in PD-L1 Positive Participants
Timepoint [2] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [4] 0 0
Objective Response Rate (ORR)
Timepoint [4] 0 0
Assessed at randomization and every 8 weeks thereafter
Secondary outcome [5] 0 0
Duration of Response (DoR)
Timepoint [5] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [6] 0 0
Disease Control Rate (DCR)
Timepoint [6] 0 0
Baseline up to 6 months; baseline up to 12 months
Secondary outcome [7] 0 0
Percentage of Participants Alive and Progression Free (APF)
Timepoint [7] 0 0
Baseline up to 6 months; baseline up to 12 months
Secondary outcome [8] 0 0
Percentage of Participants Alive
Timepoint [8] 0 0
12, 18 and 24 months
Secondary outcome [9] 0 0
Progression Free Survival (PFS) in PD-L1 Negative Participants
Timepoint [9] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [10] 0 0
Objective Response Rate (ORR) in PD-L1 Negative Participants
Timepoint [10] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [11] 0 0
Time to Deterioration in European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire, Version 3 (EORTC QLQ-C30)
Timepoint [11] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [12] 0 0
Time to Deterioration for European Organisation for Research and Treatment of Cancer 35-item Head and Neck Quality of Life Questionnaire (EORTC QLQ-H&N35)
Timepoint [12] 0 0
September 2015 to September 2018 (36 months)
Secondary outcome [13] 0 0
Number of Participants Reporting One or More Adverse Events (AE)
Timepoint [13] 0 0
First dose to last dose + 90 days or data cut off (up to 36 months)

Eligibility
Key inclusion criteria
- Age =18 years; - Written informed consent obtained from the patient/legal representative; - Histologically or cytologically confirmed recurrent or metastatic SCCHN; - Tumor progression or recurrence during or after only one palliative systemic treatment regimen for recurrent or metastatic disease that must have contained a platinum agent OR progression within 6 months of the last dose of platinum given as part of multimodality therapy with curative intent; - Confirmed PD-L1-positive or -negative SCCHN by the Ventana PD-L1 SP263 IHC assay; - WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; At least 1 measurable lesion, - Not previously irradiated; - No prior exposure to immune-mediated therapy; - Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
Minimum age
18 Years
Maximum age
96 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Histologically or cytologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck; - Received more than 1 palliative systemic regimen for recurrent or metastatic disease; -Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment; - Receipt of any investigational anticancer therapy within 28 days or 5 half-lives; - Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment; - Major surgical procedure within 28 days prior to the first dose of Investigational Product; - Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion; - Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product; - History of allogeneic organ transplantation; - Active or prior documented autoimmune or inflammatory disorders; - Uncontrolled intercurrent illness; - Patients with a history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis; - Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction; - History of active primary immunodeficiency; - Active tuberculosis; - Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV); - Receipt of live, attenuated vaccine within 30 days prior to the first dose of Investigational Product; - Pregnant or breast-feeding female patients; - Known allergy or hypersensitivity to Investigational Product

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
Open (masking not used)
Who is / are masked / blinded?



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
9/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/11/2020
Sample size
Target
Accrual to date
Final
736
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - St Leonards
Recruitment hospital [5] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
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
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
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United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
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United States of America
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Pennsylvania
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United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Caba
Country [17] 0 0
Argentina
State/province [17] 0 0
San Miguel de Tucuman
Country [18] 0 0
Belgium
State/province [18] 0 0
Brussels
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Belgium
State/province [19] 0 0
Bruxelles
Country [20] 0 0
Belgium
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Charleroi
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Namur
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Brazil
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Barretos
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Brazil
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Curitiba
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Santo Andre
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Brazil
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São José do Rio Preto
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Brazil
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São Paulo
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Bulgaria
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Shumen
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Bulgaria
State/province [32] 0 0
Sofia
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Bulgaria
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Varna
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Chile
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Temuco
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Croatia
State/province [35] 0 0
Osijek
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Croatia
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Zagreb
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Czechia
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Olomouc
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Czechia
State/province [38] 0 0
Zlin
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France
State/province [39] 0 0
Angers
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France
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Bordeaux
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France
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Dijon
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France
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Le Mans
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France
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Lyon Cedex 08
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France
State/province [44] 0 0
Montpellier Cedex 5
Country [45] 0 0
France
State/province [45] 0 0
Paris Cedex 5
Country [46] 0 0
France
State/province [46] 0 0
Plerin SUR MER
Country [47] 0 0
France
State/province [47] 0 0
Rouen
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France
State/province [48] 0 0
St Grégoire
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France
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Strasbourg Cedex
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France
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Villejuif Cedex
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Georgia
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Lorient Cedex
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Germany
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Berlin
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Germany
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Essen
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Germany
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Halle
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Germany
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Hannover
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Germany
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Heidelberg
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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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Potsdam
Country [60] 0 0
Hungary
State/province [60] 0 0
Budapest
Country [61] 0 0
Hungary
State/province [61] 0 0
Gyor
Country [62] 0 0
Hungary
State/province [62] 0 0
Kecskemét
Country [63] 0 0
Israel
State/province [63] 0 0
Haifa
Country [64] 0 0
Israel
State/province [64] 0 0
Jerusalem
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Israel
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Petach-Tikva
Country [66] 0 0
Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Aosta
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Italy
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Bologna
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Italy
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Gallarate
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Italy
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Legnago
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Italy
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Milano
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Italy
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Napoli
Country [74] 0 0
Italy
State/province [74] 0 0
Pavia
Country [75] 0 0
Italy
State/province [75] 0 0
Roma
Country [76] 0 0
Italy
State/province [76] 0 0
Siena
Country [77] 0 0
Japan
State/province [77] 0 0
Chuo-ku
Country [78] 0 0
Japan
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Fukuoka-shi
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Japan
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Hirakata-shi
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Isehara-shi
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Japan
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Kashiwa
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Japan
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Kitaadachi-gun
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Japan
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Kobe-shi
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Japan
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Koto-ku
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Japan
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Matsuyama-shi
Country [86] 0 0
Japan
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Nagoya
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Japan
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Natori-shi
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Japan
State/province [88] 0 0
Okayama
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Japan
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Osakasayama
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Japan
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Osaka
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Japan
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Sapporo
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Japan
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Shimotsuke-shi
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Japan
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Sunto-gun
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Japan
State/province [94] 0 0
Takatsuki-shi
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Japan
State/province [95] 0 0
Yokohama-shi
Country [96] 0 0
Japan
State/province [96] 0 0
Yokohama
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Korea, Republic of
State/province [97] 0 0
Daegu
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Goyang-si
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Korea, Republic of
State/province [99] 0 0
Seoul
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Korea, Republic of
State/province [100] 0 0
Suwon
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Poland
State/province [101] 0 0
Kraków
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Poland
State/province [102] 0 0
Poznan
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Poland
State/province [103] 0 0
Lódz
Country [104] 0 0
Romania
State/province [104] 0 0
Baia Mare
Country [105] 0 0
Romania
State/province [105] 0 0
Brasov
Country [106] 0 0
Romania
State/province [106] 0 0
Cluj-Napoca
Country [107] 0 0
Romania
State/province [107] 0 0
Cluj
Country [108] 0 0
Romania
State/province [108] 0 0
Craiova
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Arkhangelsk
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Chelyabinsk
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Kursk
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Moscow
Country [113] 0 0
Russian Federation
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Nizhniy Novgorod
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Omsk
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Russian Federation
State/province [115] 0 0
Pyatigorsk
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Saint Petersburg
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Russian Federation
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Saint-Petersburg
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Sankt-Peterburg
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Sochi
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Ufa
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Vladimir
Country [122] 0 0
Serbia
State/province [122] 0 0
Belgrade
Country [123] 0 0
Serbia
State/province [123] 0 0
Belgrad
Country [124] 0 0
Serbia
State/province [124] 0 0
Kragujevac
Country [125] 0 0
Serbia
State/province [125] 0 0
Nis
Country [126] 0 0
Serbia
State/province [126] 0 0
Sremska Kamenica
Country [127] 0 0
Spain
State/province [127] 0 0
Barcelona
Country [128] 0 0
Spain
State/province [128] 0 0
L'Hospitalet de Llobregat
Country [129] 0 0
Spain
State/province [129] 0 0
Madrid
Country [130] 0 0
Spain
State/province [130] 0 0
Malaga
Country [131] 0 0
Spain
State/province [131] 0 0
Marbella
Country [132] 0 0
Spain
State/province [132] 0 0
Pamplona
Country [133] 0 0
Spain
State/province [133] 0 0
Valencia
Country [134] 0 0
Spain
State/province [134] 0 0
Zaragoza
Country [135] 0 0
Taiwan
State/province [135] 0 0
Kaohsiung
Country [136] 0 0
Taiwan
State/province [136] 0 0
Taipei
Country [137] 0 0
Taiwan
State/province [137] 0 0
Taoynan
Country [138] 0 0
Ukraine
State/province [138] 0 0
Dnipro
Country [139] 0 0
Ukraine
State/province [139] 0 0
Kyiv
Country [140] 0 0
Ukraine
State/province [140] 0 0
Sumy
Country [141] 0 0
Ukraine
State/province [141] 0 0
Uzhhorod
Country [142] 0 0
Ukraine
State/province [142] 0 0
Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Nassim Morsli, MD
Address 0 0
Medical Director AstraZeneca
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/NCT02369874