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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the NCI-CTCAE version 4.0, where Grade 1 indicates "Mild" severity and Grade 5 indicates "Death". The CTCAE defines Grades 3 and 4 as follows: Grade 3 means "Severe"; Inability to work or perform normal daily activity; treatment or medical intervention is indicated in order to improve the overall well-being or symptoms; delaying the onset of treatment is not putting the survival of the participant at direct risk. Grade 4 means "Life-threatening, Disabling"; based on extreme limitation in activity; significant medical intervention/therapy required; and hospitalization probable.
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 - An AE was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Pre existing conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Percentage of participants with dose interruption or discontinuation due to AE was presented.
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 - AEs of special interest included cutaneous squamous cell carcinoma (SCC), rash, photosensitivity, liver injury, arthralgia, fatigue, gastrointestinal (GI) polyps, pancreatitis, potentiation of radiation toxicity, prolongation of cardiac repolarization or arrhythmia, non-cutaneous SCC and other primary malignancies (other than cutaneous SCC or new primary melanoma).
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 - Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.
Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation.
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 - Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.
Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. Average total dose per day: total actual dose taken divided by total actual days on treatment.
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 - Dose intensity was defined as (total actual doses taken/total planned doses) *100, where total planned doses = prescribed doses * planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.
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 - ECOG Performance Status was measured on-therapy assessed participant's performance status on 5 point scale: 0 = fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Percentage of participants who had at least one point improvement from baseline at any assessment visit as well as at last study visit was reported.
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 - Concomitant medications were all medications taken during the study, including those started before but ongoing at first dose. No medications for Melanoma were included. Percentage of participants who received at least one concomitant medication was reported.
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) - BOR was assessed by the investigator according to RECIST v1.1. BOR was defined as having confirmed CR or PR. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions.
Confirmed responses were those that persisted on repeat imaging greater than or equal to (>=) 4 weeks after initial response.
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 - The duration of response was defined as the time between the date of first confirmed CR or PR and date of first progression of disease (PD), or death, from any cause. Responses were assessed as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response. PD: at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.
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 - Time to response was defined as the time between the date of first treatment and date of first confirmed CR or PR (assessed as per RECIST v1.1). CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial 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 - PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.
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) - PFS was defined as the time between the date of the first treatment and the date of first progression or death from any cause. PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.
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) - Overall Survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.
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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [12] 0 0
Belgium
State/province [12] 0 0
Wilrijk
Country [13] 0 0
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
Country [16] 0 0
Brazil
State/province [16] 0 0
RS
Country [17] 0 0
Brazil
State/province [17] 0 0
SP
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Plovdiv
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Manitoba
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Colombia
State/province [26] 0 0
Bogota
Country [27] 0 0
Colombia
State/province [27] 0 0
Cali
Country [28] 0 0
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
Country [43] 0 0
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
Country [46] 0 0
Germany
State/province [46] 0 0
Aachen
Country [47] 0 0
Germany
State/province [47] 0 0
Augsburg
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Bochum
Country [50] 0 0
Germany
State/province [50] 0 0
Buxtehude
Country [51] 0 0
Germany
State/province [51] 0 0
Chemnitz
Country [52] 0 0
Germany
State/province [52] 0 0
Dresden
Country [53] 0 0
Germany
State/province [53] 0 0
Düsseldorf
Country [54] 0 0
Germany
State/province [54] 0 0
Erfurt
Country [55] 0 0
Germany
State/province [55] 0 0
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
Country [65] 0 0
Germany
State/province [65] 0 0
Jena
Country [66] 0 0
Germany
State/province [66] 0 0
Kassel
Country [67] 0 0
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
Country [73] 0 0
Germany
State/province [73] 0 0
Mainz
Country [74] 0 0
Germany
State/province [74] 0 0
Mannheim
Country [75] 0 0
Germany
State/province [75] 0 0
Marburg
Country [76] 0 0
Germany
State/province [76] 0 0
Minden
Country [77] 0 0
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
State/province [122] 0 0
Daugavpils
Country [123] 0 0
Latvia
State/province [123] 0 0
Riga
Country [124] 0 0
Lithuania
State/province [124] 0 0
Klaipeda
Country [125] 0 0
Lithuania
State/province [125] 0 0
Vilnius
Country [126] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [126] 0 0
Skopje
Country [127] 0 0
Mexico
State/province [127] 0 0
Leon
Country [128] 0 0
Mexico
State/province [128] 0 0
Mexico City
Country [129] 0 0
Mexico
State/province [129] 0 0
Mexico DF
Country [130] 0 0
Netherlands
State/province [130] 0 0
Amsterdam
Country [131] 0 0
Netherlands
State/province [131] 0 0
Blaricum
Country [132] 0 0
Netherlands
State/province [132] 0 0
Breda
Country [133] 0 0
Netherlands
State/province [133] 0 0
Groningen
Country [134] 0 0
Netherlands
State/province [134] 0 0
Leiden
Country [135] 0 0
Netherlands
State/province [135] 0 0
Maastricht
Country [136] 0 0
Netherlands
State/province [136] 0 0
Nijmegen
Country [137] 0 0
Netherlands
State/province [137] 0 0
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
State/province [146] 0 0
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This multi-center study evaluates the safety and efficacy of vemurafenib in participants with
BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV
(American Joint Committee on Cancer [AJCC]) metastatic melanoma.
Trial website
https://clinicaltrials.gov/show/NCT01307397
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

Summary results
Other publications