Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01456325




Registration number
NCT01456325
Ethics application status
Date submitted
18/10/2011
Date registered
20/10/2011
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)
Scientific title
A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease
Secondary ID [1] 0 0
GO27761
Secondary ID [2] 0 0
OAM4971g
Universal Trial Number (UTN)
Trial acronym
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 - Erlotinib
Treatment: Drugs - Onartuzumab (MetMab)
Treatment: Drugs - Placebo

Experimental: Onartuzumab+Erlotinib - Participants will receive onartuzumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally once daily (QD) from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.

Placebo comparator: Placebo+Erlotinib - Participants will receive onartuzumab matching placebo on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally QD from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.


Treatment: Drugs: Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.

Treatment: Drugs: Onartuzumab (MetMab)
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.

Treatment: Drugs: Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Secondary outcome [1] 0 0
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores
Timepoint [1] 0 0
Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months)
Secondary outcome [2] 0 0
Onartuzumab Serum Concentrations
Timepoint [2] 0 0
1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months)
Secondary outcome [3] 0 0
Percentage of Participants With Disease Progression or Death
Timepoint [3] 0 0
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Secondary outcome [5] 0 0
Percentage of Participants with an Objective Response Assessed Using RECIST V 1.1
Timepoint [5] 0 0
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)

Eligibility
Key inclusion criteria
* Adult participants, greater than or equal to (>/=) 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
* Met diagnostic-positive status tested by immunohistochemistry (IHC)
* Results of endothelial growth factor receptor (EGFR)-activating mutation testing
* Radiographic evidence of disease
* Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1
* availability of tissue sample for diagnostic testing is required
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications (EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)
* Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days
* History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligible
* Inadequate hematological, biochemical or organ function
* Significant history of cardiac disease
* Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
* Any inflammatory changes of the surface of the eye
* Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
* Pregnant or lactating women
* Positive for human immunodefinciency (HIV) infection

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
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
494
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Chermside
Recruitment hospital [4] 0 0
- Adelaide
Recruitment hospital [5] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
5041 - Adelaide
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Florida
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Illinois
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Iowa
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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Nevada
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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Virginia
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Argentina
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La Plata
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Argentina
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Quilmes
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Argentina
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Santa Fe
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Gilly (Charleroi)
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Belgium
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Liège
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Belgium
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Namur
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Brazil
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BA
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Brazil
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RS
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Brazil
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SP
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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Chile
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Temuco
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Croatia
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Cakovec
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Croatia
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Dubrovnik
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Croatia
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Pula
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Croatia
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Zagreb
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France
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Besancon
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Caen
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France
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Grenoble
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Limoges
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France
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Marseille
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France
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Montpellier
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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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Saint Herblain
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France
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Suresnes
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France
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Vandoeuvre-les-nancy
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Germany
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Bad Berka
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Germany
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Berlin
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Germany
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Grosshansdorf
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Karlsruhe
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Germany
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Mainz
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Germany
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München
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Germany
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Oldenburg
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Germany
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Regensburg
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Germany
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Ulm
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Germany
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Villingen-Schwenningen
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Hong Kong
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Pokfulam
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Hong Kong
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Shatin
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Hungary
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Edeleny
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Hungary
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Miskolc
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Hungary
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Szombathely
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Ireland
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Cork
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Ireland
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Dublin
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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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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petach 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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Italy
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Friuli-Venezia Giulia
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Marche
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Italy
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Piemonte
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Italy
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Toscana
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Italy
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Umbria
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Japan
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Aichi
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Chiba
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Ehime
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Fukuoka
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Hyogo
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Kanagawa
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Kyoto
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Japan
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Miyagi
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Okayama
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Yamaguchi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Maastricht
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Peru
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Lima
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Poland
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Gdansk
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Poland
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Krakow
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Lodz
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Olsztyn
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Poland
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Poznan
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Russian Federation
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Ivanovo
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Russian Federation
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Krasnodar
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Russian Federation
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Omsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Serbia
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Belgrade
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Serbia
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Kragujevac
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South Africa
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Bloemfontein
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South Africa
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Johannesburg
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South Africa
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Sandton
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Ukraine
State/province [130] 0 0
Cherkassy
Country [131] 0 0
Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Ukraine
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Sumy
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Ukraine
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Zaporizhzhya
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Belfast
Country [136] 0 0
United Kingdom
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Grimsby
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United Kingdom
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Leicester
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United Kingdom
State/province [138] 0 0
London
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
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
Ivor Caro, M.D.
Address 0 0
Genentech, Inc.
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 not provided in https://clinicaltrials.gov/study/NCT01456325