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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02008227




Registration number
NCT02008227
Ethics application status
Date submitted
6/12/2013
Date registered
11/12/2013
Date last updated
20/12/2019

Titles & IDs
Public title
A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
Scientific title
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Secondary ID [1] 0 0
2013-003331-30
Secondary ID [2] 0 0
GO28915
Universal Trial Number (UTN)
Trial acronym
OAK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

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

Experimental: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody - Atezolizumab 1200 milligrams (mg) was administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.

Active comparator: Docetaxel - Docetaxel 75 milligrams per meter square (mg/m\^2) was administered via IV infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.


Treatment: Drugs: Atezolizumab
1200 mg IV infusion on Day 1 of each 21-day cycle

Treatment: Drugs: Docetaxel
75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Died: PP-ITT
Timepoint [1] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [2] 0 0
Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
Timepoint [2] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [3] 0 0
Overall Survival (OS): PP-ITT
Timepoint [3] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [4] 0 0
OS: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [4] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [5] 0 0
OS: SP-ITT
Timepoint [5] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Primary outcome [6] 0 0
OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
Timepoint [6] 0 0
Baseline until death from any cause (approximately 2.87 years)
Primary outcome [7] 0 0
OS: TC2/3 or IC2/3 Subgroup of SP
Timepoint [7] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Primary outcome [8] 0 0
OS: TC3 or IC3 Subgroup of SP
Timepoint [8] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Secondary outcome [1] 0 0
Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
Timepoint [1] 0 0
Baseline up to PD or Death (up to approximately 2.25 years)
Secondary outcome [2] 0 0
Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [2] 0 0
Baseline up to PD or Death (up to approximately 2.25 years)
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
Timepoint [3] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [4] 0 0
PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [4] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [5] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
Timepoint [5] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [6] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [6] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [7] 0 0
Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
Timepoint [7] 0 0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [8] 0 0
DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [8] 0 0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [9] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Timepoint [9] 0 0
Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])
Secondary outcome [10] 0 0
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Timepoint [10] 0 0
Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)
Secondary outcome [11] 0 0
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Timepoint [11] 0 0
Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)
Secondary outcome [12] 0 0
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Timepoint [12] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
Secondary outcome [13] 0 0
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Timepoint [13] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [14] 0 0
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Timepoint [14] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [15] 0 0
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Timepoint [15] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [16] 0 0
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Timepoint [16] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [17] 0 0
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Timepoint [17] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [18] 0 0
EORTC QLQ-LC13 Questionnaire Score: Coughing
Timepoint [18] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [19] 0 0
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Timepoint [19] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [20] 0 0
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Timepoint [20] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [21] 0 0
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Timepoint [21] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [22] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Timepoint [22] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [23] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Timepoint [23] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [24] 0 0
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Timepoint [24] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [25] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Timepoint [25] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [26] 0 0
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Timepoint [26] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [27] 0 0
PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
Timepoint [27] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Secondary outcome [28] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
Timepoint [28] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Secondary outcome [29] 0 0
DOR as Determined by Investigator Using RECIST v1.1: SP ITT
Timepoint [29] 0 0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)

Eligibility
Key inclusion criteria
* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
* Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known active or untreated central nervous system (CNS) metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Active hepatitis B or hepatitis C
* Prior treatment with docetaxel
* Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

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
11/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2019
Sample size
Target
Accrual to date
Final
1225
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Montana
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Córdoba
Country [25] 0 0
Argentina
State/province [25] 0 0
Provincia De Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Rosario
Country [27] 0 0
Austria
State/province [27] 0 0
Innsbruck
Country [28] 0 0
Austria
State/province [28] 0 0
Salzburg
Country [29] 0 0
Austria
State/province [29] 0 0
Vöcklabruck
Country [30] 0 0
Brazil
State/province [30] 0 0
RS
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Chile
State/province [34] 0 0
Recoleta
Country [35] 0 0
Chile
State/province [35] 0 0
Temuco
Country [36] 0 0
Chile
State/province [36] 0 0
Vina Del Mar
Country [37] 0 0
Finland
State/province [37] 0 0
Helsinki
Country [38] 0 0
Finland
State/province [38] 0 0
Oulu
Country [39] 0 0
Finland
State/province [39] 0 0
Tampere
Country [40] 0 0
France
State/province [40] 0 0
Avignon
Country [41] 0 0
France
State/province [41] 0 0
Besancon
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France
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Bordeaux
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France
State/province [43] 0 0
Caen
Country [44] 0 0
France
State/province [44] 0 0
Creteil
Country [45] 0 0
France
State/province [45] 0 0
Grenoble
Country [46] 0 0
France
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Le Mans
Country [47] 0 0
France
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Lille
Country [48] 0 0
France
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Marseille
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France
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Mulhouse
Country [50] 0 0
France
State/province [50] 0 0
Paris
Country [51] 0 0
France
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Pierre Benite
Country [52] 0 0
France
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Pringy
Country [53] 0 0
France
State/province [53] 0 0
Rennes
Country [54] 0 0
France
State/province [54] 0 0
Strasbourg
Country [55] 0 0
France
State/province [55] 0 0
Suresnes
Country [56] 0 0
France
State/province [56] 0 0
Toulon
Country [57] 0 0
France
State/province [57] 0 0
Toulouse
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Frankfurt
Country [60] 0 0
Germany
State/province [60] 0 0
Gauting
Country [61] 0 0
Germany
State/province [61] 0 0
Halle
Country [62] 0 0
Germany
State/province [62] 0 0
Heidelberg
Country [63] 0 0
Germany
State/province [63] 0 0
Hemer
Country [64] 0 0
Germany
State/province [64] 0 0
Immenhausen
Country [65] 0 0
Germany
State/province [65] 0 0
Köln
Country [66] 0 0
Germany
State/province [66] 0 0
Regensburg
Country [67] 0 0
Greece
State/province [67] 0 0
Athens
Country [68] 0 0
Greece
State/province [68] 0 0
Patras
Country [69] 0 0
Greece
State/province [69] 0 0
Thermi Thessalonikis
Country [70] 0 0
Guatemala
State/province [70] 0 0
Guatemala City
Country [71] 0 0
Hungary
State/province [71] 0 0
Budapest
Country [72] 0 0
Hungary
State/province [72] 0 0
Pecs
Country [73] 0 0
Hungary
State/province [73] 0 0
Torokbalint
Country [74] 0 0
Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
State/province [78] 0 0
Liguria
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Italy
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Lombardia
Country [80] 0 0
Italy
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Puglia
Country [81] 0 0
Italy
State/province [81] 0 0
Sicilia
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Italy
State/province [82] 0 0
Toscana
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Italy
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Veneto
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Japan
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Aichi
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Japan
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Chiba
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Japan
State/province [86] 0 0
Ehime
Country [87] 0 0
Japan
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Fukuoka
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Japan
State/province [88] 0 0
Hyogo
Country [89] 0 0
Japan
State/province [89] 0 0
Miyagi
Country [90] 0 0
Japan
State/province [90] 0 0
Okayama
Country [91] 0 0
Japan
State/province [91] 0 0
Osaka
Country [92] 0 0
Japan
State/province [92] 0 0
Saitama
Country [93] 0 0
Japan
State/province [93] 0 0
Shizuoka
Country [94] 0 0
Japan
State/province [94] 0 0
Tokyo
Country [95] 0 0
Japan
State/province [95] 0 0
Yamaguchi
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Gyeonggi-do
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
Netherlands
State/province [98] 0 0
'S Hertogenbosch
Country [99] 0 0
Netherlands
State/province [99] 0 0
Eindhoven
Country [100] 0 0
Netherlands
State/province [100] 0 0
Nieuwegein
Country [101] 0 0
New Zealand
State/province [101] 0 0
Auckland
Country [102] 0 0
New Zealand
State/province [102] 0 0
Dunedin
Country [103] 0 0
New Zealand
State/province [103] 0 0
Hamilton
Country [104] 0 0
Norway
State/province [104] 0 0
Oslo
Country [105] 0 0
Panama
State/province [105] 0 0
Panama
Country [106] 0 0
Poland
State/province [106] 0 0
Gdansk
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Poland
State/province [107] 0 0
Lodz
Country [108] 0 0
Poland
State/province [108] 0 0
Otwock
Country [109] 0 0
Poland
State/province [109] 0 0
Poznan
Country [110] 0 0
Poland
State/province [110] 0 0
Warszawa
Country [111] 0 0
Portugal
State/province [111] 0 0
Coimbra
Country [112] 0 0
Portugal
State/province [112] 0 0
Lisboa
Country [113] 0 0
Portugal
State/province [113] 0 0
Porto
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Moscow
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Saint-Petersburg
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Samara
Country [117] 0 0
Serbia
State/province [117] 0 0
Belgrade
Country [118] 0 0
Serbia
State/province [118] 0 0
Sremska Kamenica
Country [119] 0 0
Spain
State/province [119] 0 0
LAS Palmas
Country [120] 0 0
Spain
State/province [120] 0 0
Madrid
Country [121] 0 0
Spain
State/province [121] 0 0
La Coruña
Country [122] 0 0
Spain
State/province [122] 0 0
Malaga
Country [123] 0 0
Spain
State/province [123] 0 0
Zaragoza
Country [124] 0 0
Sweden
State/province [124] 0 0
Goeteborg
Country [125] 0 0
Sweden
State/province [125] 0 0
Linköping
Country [126] 0 0
Sweden
State/province [126] 0 0
Stockholm
Country [127] 0 0
Switzerland
State/province [127] 0 0
Baden
Country [128] 0 0
Switzerland
State/province [128] 0 0
Geneve
Country [129] 0 0
Switzerland
State/province [129] 0 0
Luzern
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taichung
Country [131] 0 0
Taiwan
State/province [131] 0 0
Taipei
Country [132] 0 0
Taiwan
State/province [132] 0 0
Taoyuan
Country [133] 0 0
Thailand
State/province [133] 0 0
Bangkok
Country [134] 0 0
Turkey
State/province [134] 0 0
Istanbul
Country [135] 0 0
Turkey
State/province [135] 0 0
Izmir
Country [136] 0 0
Ukraine
State/province [136] 0 0
Dnipropetrovsk
Country [137] 0 0
Ukraine
State/province [137] 0 0
Kharkiv
Country [138] 0 0
Ukraine
State/province [138] 0 0
Uzhgorod
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Grimsby
Country [140] 0 0
United Kingdom
State/province [140] 0 0
London
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Manchester
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Sutton in Ashfield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02008227