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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01307397




Registration number
NCT01307397
Ethics application status
Date submitted
17/02/2011
Date registered
2/03/2011
Date last updated
18/12/2017

Titles & IDs
Public title
A Study of Vemurafenib in Participants With Metastatic Melanoma
Scientific title
An Open-Label, Multicenter Study to Assess the Safety of RO5185426 (Vemurafenib) in Patients With Metastatic Melanoma
Secondary ID [1] 0 0
2010-023526-21
Secondary ID [2] 0 0
MO25515
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

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

Experimental: Vemurafenib - Participants will receive vemurafenib at a dose of 960 milligrams (mg) twice daily (bid) until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.


Treatment: Drugs: Vemurafenib
Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0
Timepoint [1] 0 0
Baseline up to 28 days post end of treatment (maximum up to 46 months)
Primary outcome [2] 0 0
Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation
Timepoint [2] 0 0
Baseline up to 28 days post end of treatment (maximum up to 46 months)
Primary outcome [3] 0 0
Percentage of Participants With AEs of Special Interest
Timepoint [3] 0 0
Baseline up to 28 days post end of treatment (maximum up to 46 months)
Primary outcome [4] 0 0
Mean Cumulative Dose of Vemurafenib
Timepoint [4] 0 0
Baseline up to end of treatment or death (maximum up to 46 months)
Primary outcome [5] 0 0
Duration of Vemurafenib Treatment
Timepoint [5] 0 0
Baseline up to end of treatment or death (maximum upto 46 months)
Primary outcome [6] 0 0
Mean Total Vemurafenib Dose Per Day
Timepoint [6] 0 0
Baseline up to end of treatment or death (maximum up to 46 months)
Primary outcome [7] 0 0
Dose Intensity of Vemurafenib
Timepoint [7] 0 0
Baseline up to end of treatment or death (maximum upto 46 months)
Secondary outcome [1] 0 0
Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status
Timepoint [1] 0 0
Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)
Secondary outcome [2] 0 0
Percentage of Participants Who Received Any Concomitant Medications
Timepoint [2] 0 0
Baseline up to 46 months
Secondary outcome [3] 0 0
Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Timepoint [3] 0 0
Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months])
Secondary outcome [5] 0 0
Time to Response
Timepoint [5] 0 0
Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Secondary outcome [6] 0 0
Percentage of Participants With PD Assessed According to RECIST v1.1 or Death
Timepoint [6] 0 0
Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Secondary outcome [7] 0 0
Progression Free Survival (PFS)
Timepoint [7] 0 0
Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Secondary outcome [8] 0 0
Percentage of Participants Who Died
Timepoint [8] 0 0
Baseline until death (maximum up to 46 months)
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
Baseline until death (maximum up to 46 months)

Eligibility
Key inclusion criteria
* Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
* Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
* Participants may or may not have received prior systemic therapy for metastatic melanoma
* Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
* Adequate hematologic, renal and liver function
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
* Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
* Concurrent administration of any anti-cancer therapies other than those administered in the study
* Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
* Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
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
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/02/2016
Sample size
Target
Accrual to date
Final
3219
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [2] 0 0
Newcastle Mater Misericordiae Hospital; Oncology - Waratah
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [5] 0 0
Greenslopes Private Hospital; Gallipoli Research Centre - Greenslopes
Recruitment hospital [6] 0 0
The Townsville Hospital; Townsville Cancer Centre - Townsville
Recruitment hospital [7] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital; Oncology - Adelaide
Recruitment hospital [9] 0 0
Geelong Hospital; Geelong Cardiology Practice - Geelong
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment hospital [11] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
4812 - Townsville
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Albania
State/province [1] 0 0
Tirana
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Feldkirch
Country [4] 0 0
Austria
State/province [4] 0 0
Graz
Country [5] 0 0
Austria
State/province [5] 0 0
Innsbruck
Country [6] 0 0
Austria
State/province [6] 0 0
Linz
Country [7] 0 0
Austria
State/province [7] 0 0
Salzburg
Country [8] 0 0
Austria
State/province [8] 0 0
St. Pölten
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussel
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
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Belgium
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Wilrijk
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Bosnia and Herzegovina
State/province [13] 0 0
Banja Luka
Country [14] 0 0
Bosnia and Herzegovina
State/province [14] 0 0
Sarajevo
Country [15] 0 0
Brazil
State/province [15] 0 0
RJ
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Brazil
State/province [16] 0 0
RS
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Brazil
State/province [17] 0 0
SP
Country [18] 0 0
Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Quebec
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Colombia
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Bogota
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Cali
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Colombia
State/province [28] 0 0
Medellin-Antioquia
Country [29] 0 0
Croatia
State/province [29] 0 0
Zagreb
Country [30] 0 0
Czechia
State/province [30] 0 0
Brno
Country [31] 0 0
Czechia
State/province [31] 0 0
Hradec Kralove
Country [32] 0 0
Czechia
State/province [32] 0 0
Olomouc
Country [33] 0 0
Czechia
State/province [33] 0 0
Ostrava
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha
Country [35] 0 0
Denmark
State/province [35] 0 0
Aarhus C
Country [36] 0 0
Denmark
State/province [36] 0 0
Herlev
Country [37] 0 0
Denmark
State/province [37] 0 0
Odense
Country [38] 0 0
Ecuador
State/province [38] 0 0
Cuenca
Country [39] 0 0
Ecuador
State/province [39] 0 0
Guayaquil
Country [40] 0 0
Ecuador
State/province [40] 0 0
Portoviejo
Country [41] 0 0
Estonia
State/province [41] 0 0
Tallinn
Country [42] 0 0
Estonia
State/province [42] 0 0
Tartu
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Finland
State/province [43] 0 0
Helsinki
Country [44] 0 0
Finland
State/province [44] 0 0
Tampere
Country [45] 0 0
Finland
State/province [45] 0 0
Turku
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Germany
State/province [46] 0 0
Aachen
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Germany
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Augsburg
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Berlin
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Germany
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Bochum
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Germany
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Buxtehude
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Germany
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Chemnitz
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Germany
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Dresden
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Düsseldorf
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Germany
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Erfurt
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Germany
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Erlangen
Country [56] 0 0
Germany
State/province [56] 0 0
Essen
Country [57] 0 0
Germany
State/province [57] 0 0
Frankfurt
Country [58] 0 0
Germany
State/province [58] 0 0
Freiburg
Country [59] 0 0
Germany
State/province [59] 0 0
Gera
Country [60] 0 0
Germany
State/province [60] 0 0
Göttingen
Country [61] 0 0
Germany
State/province [61] 0 0
Hamburg
Country [62] 0 0
Germany
State/province [62] 0 0
Hannover
Country [63] 0 0
Germany
State/province [63] 0 0
Heidelberg
Country [64] 0 0
Germany
State/province [64] 0 0
Heilbronn
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Germany
State/province [65] 0 0
Jena
Country [66] 0 0
Germany
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Kassel
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Germany
State/province [67] 0 0
Kiel
Country [68] 0 0
Germany
State/province [68] 0 0
Köln
Country [69] 0 0
Germany
State/province [69] 0 0
Leipzig
Country [70] 0 0
Germany
State/province [70] 0 0
Ludwigshafen
Country [71] 0 0
Germany
State/province [71] 0 0
Lübeck
Country [72] 0 0
Germany
State/province [72] 0 0
Magdeburg
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Germany
State/province [73] 0 0
Mainz
Country [74] 0 0
Germany
State/province [74] 0 0
Mannheim
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Germany
State/province [75] 0 0
Marburg
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Germany
State/province [76] 0 0
Minden
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Germany
State/province [77] 0 0
München
Country [78] 0 0
Germany
State/province [78] 0 0
Münster
Country [79] 0 0
Germany
State/province [79] 0 0
Nürnberg
Country [80] 0 0
Germany
State/province [80] 0 0
Quedlinburg
Country [81] 0 0
Germany
State/province [81] 0 0
Recklinghausen
Country [82] 0 0
Germany
State/province [82] 0 0
Regensburg
Country [83] 0 0
Germany
State/province [83] 0 0
Tübingen
Country [84] 0 0
Germany
State/province [84] 0 0
Wiesbaden
Country [85] 0 0
Germany
State/province [85] 0 0
Wuppertal
Country [86] 0 0
Germany
State/province [86] 0 0
Würzburg
Country [87] 0 0
Greece
State/province [87] 0 0
Athens
Country [88] 0 0
Greece
State/province [88] 0 0
Heraklion
Country [89] 0 0
Greece
State/province [89] 0 0
Piraeus
Country [90] 0 0
Hungary
State/province [90] 0 0
Budapest
Country [91] 0 0
Hungary
State/province [91] 0 0
Debrecen
Country [92] 0 0
Hungary
State/province [92] 0 0
Pecs
Country [93] 0 0
Hungary
State/province [93] 0 0
Szeged
Country [94] 0 0
India
State/province [94] 0 0
Delhi
Country [95] 0 0
India
State/province [95] 0 0
Maharashtra
Country [96] 0 0
India
State/province [96] 0 0
Hyderabad
Country [97] 0 0
India
State/province [97] 0 0
Lucknow
Country [98] 0 0
India
State/province [98] 0 0
Trivandrum
Country [99] 0 0
India
State/province [99] 0 0
Vellore
Country [100] 0 0
Ireland
State/province [100] 0 0
Cork
Country [101] 0 0
Ireland
State/province [101] 0 0
Dublin
Country [102] 0 0
Ireland
State/province [102] 0 0
Galway
Country [103] 0 0
Ireland
State/province [103] 0 0
Limerick
Country [104] 0 0
Ireland
State/province [104] 0 0
Waterford
Country [105] 0 0
Israel
State/province [105] 0 0
Beer Sheva
Country [106] 0 0
Israel
State/province [106] 0 0
Hafia
Country [107] 0 0
Israel
State/province [107] 0 0
Jerusalem
Country [108] 0 0
Israel
State/province [108] 0 0
Ramat Gan
Country [109] 0 0
Italy
State/province [109] 0 0
Campania
Country [110] 0 0
Italy
State/province [110] 0 0
Emilia-Romagna
Country [111] 0 0
Italy
State/province [111] 0 0
Friuli-Venezia Giulia
Country [112] 0 0
Italy
State/province [112] 0 0
Lazio
Country [113] 0 0
Italy
State/province [113] 0 0
Liguria
Country [114] 0 0
Italy
State/province [114] 0 0
Lombardia
Country [115] 0 0
Italy
State/province [115] 0 0
Piemonte
Country [116] 0 0
Italy
State/province [116] 0 0
Puglia
Country [117] 0 0
Italy
State/province [117] 0 0
Sicilia
Country [118] 0 0
Italy
State/province [118] 0 0
Toscana
Country [119] 0 0
Italy
State/province [119] 0 0
Umbria
Country [120] 0 0
Italy
State/province [120] 0 0
Veneto
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Seoul
Country [122] 0 0
Latvia
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Daugavpils
Country [123] 0 0
Latvia
State/province [123] 0 0
Riga
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Lithuania
State/province [124] 0 0
Klaipeda
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Lithuania
State/province [125] 0 0
Vilnius
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Macedonia, The Former Yugoslav Republic of
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Skopje
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Mexico
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Leon
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Mexico
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Mexico City
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Mexico
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Mexico DF
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Netherlands
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Amsterdam
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Netherlands
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Blaricum
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Netherlands
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Breda
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Netherlands
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Groningen
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Netherlands
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Leiden
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Netherlands
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Maastricht
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
Country [138] 0 0
Netherlands
State/province [138] 0 0
Utrecht
Country [139] 0 0
Norway
State/province [139] 0 0
Bergen
Country [140] 0 0
Norway
State/province [140] 0 0
Oslo
Country [141] 0 0
Peru
State/province [141] 0 0
Arequipa
Country [142] 0 0
Peru
State/province [142] 0 0
Lima
Country [143] 0 0
Poland
State/province [143] 0 0
Krakow
Country [144] 0 0
Poland
State/province [144] 0 0
Olsztyn
Country [145] 0 0
Poland
State/province [145] 0 0
Poznan
Country [146] 0 0
Poland
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Warszawa
Country [147] 0 0
Portugal
State/province [147] 0 0
Lisboa
Country [148] 0 0
Portugal
State/province [148] 0 0
Porto
Country [149] 0 0
Romania
State/province [149] 0 0
Bucuresti
Country [150] 0 0
Romania
State/province [150] 0 0
Cluj-Napoca
Country [151] 0 0
Romania
State/province [151] 0 0
Timisoara
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Leningrad
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Krasnodar
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Moscow
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Russian Federation
State/province [155] 0 0
Saint-Petersburg
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Stavropol
Country [157] 0 0
Russian Federation
State/province [157] 0 0
UFA
Country [158] 0 0
Serbia
State/province [158] 0 0
Belgrade
Country [159] 0 0
Slovakia
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Bratislava
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Slovakia
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Poprad
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Slovenia
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Ljubljana
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Pretoria
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South Africa
State/province [166] 0 0
Sandton
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Spain
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Asturias
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Spain
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Cantabria
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Spain
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Islas Baleares
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Spain
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Las Palmas
Country [171] 0 0
Spain
State/province [171] 0 0
Murcia
Country [172] 0 0
Spain
State/province [172] 0 0
Navarra
Country [173] 0 0
Spain
State/province [173] 0 0
Pontevedra
Country [174] 0 0
Spain
State/province [174] 0 0
Tenerife
Country [175] 0 0
Spain
State/province [175] 0 0
Vizcaya
Country [176] 0 0
Spain
State/province [176] 0 0
Barcelona
Country [177] 0 0
Spain
State/province [177] 0 0
Cordoba
Country [178] 0 0
Spain
State/province [178] 0 0
Granada
Country [179] 0 0
Spain
State/province [179] 0 0
La Coruña
Country [180] 0 0
Spain
State/province [180] 0 0
Leon
Country [181] 0 0
Spain
State/province [181] 0 0
Madrid
Country [182] 0 0
Spain
State/province [182] 0 0
Malaga
Country [183] 0 0
Spain
State/province [183] 0 0
Salamanca
Country [184] 0 0
Spain
State/province [184] 0 0
Sevilla
Country [185] 0 0
Spain
State/province [185] 0 0
Valencia
Country [186] 0 0
Spain
State/province [186] 0 0
Zaragoza
Country [187] 0 0
Sweden
State/province [187] 0 0
Gothenburg
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Sweden
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Lund
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Sweden
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Stockholm
Country [190] 0 0
Sweden
State/province [190] 0 0
Umeå
Country [191] 0 0
Sweden
State/province [191] 0 0
Uppsala
Country [192] 0 0
Switzerland
State/province [192] 0 0
Basel
Country [193] 0 0
Switzerland
State/province [193] 0 0
Bern
Country [194] 0 0
Switzerland
State/province [194] 0 0
Chur
Country [195] 0 0
Switzerland
State/province [195] 0 0
Lausanne
Country [196] 0 0
Switzerland
State/province [196] 0 0
St. Gallen
Country [197] 0 0
Switzerland
State/province [197] 0 0
Zürich
Country [198] 0 0
Turkey
State/province [198] 0 0
Adana
Country [199] 0 0
Turkey
State/province [199] 0 0
Ankara
Country [200] 0 0
Turkey
State/province [200] 0 0
Antalya
Country [201] 0 0
Turkey
State/province [201] 0 0
Bornova, IZMIR
Country [202] 0 0
Turkey
State/province [202] 0 0
Gaziantep
Country [203] 0 0
Turkey
State/province [203] 0 0
Istanbul
Country [204] 0 0
Turkey
State/province [204] 0 0
Izmir
Country [205] 0 0
Turkey
State/province [205] 0 0
Sihhiye, ANKARA
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Cambridge
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Glasgow
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Guildford
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Leeds
Country [210] 0 0
United Kingdom
State/province [210] 0 0
London
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Manchester
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Newcastle upon Tyne
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Northwood
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Nottingham
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Oxford
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Southampton
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Swansea

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/NCT01307397