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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01006980




Registration number
NCT01006980
Ethics application status
Date submitted
30/10/2009
Date registered
3/11/2009
Date last updated
28/09/2016

Titles & IDs
Public title
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
Scientific title
BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine
Secondary ID [1] 0 0
2009-012293-12
Secondary ID [2] 0 0
NO25026
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
Treatment: Drugs - Dacarbazine

Experimental: Vemurafenib -

Active comparator: Dacarbazine -


Treatment: Drugs: Vemurafenib
960 mg (as 240 mg tables) orally twice daily

Treatment: Drugs: Dacarbazine
1000 mg/m2 intravenously every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).
Primary outcome [2] 0 0
Progression-free Survival
Timepoint [2] 0 0
From randomization (initiated January 2010) to December 30 2010.
Secondary outcome [1] 0 0
Participants With a Best Overall Response (BOR) of Complete Response or Partial Response
Timepoint [1] 0 0
From randomization (initiated January 2010) until December 30, 2010
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
From randomization (initiated in January 2010) until December 30, 2010.
Secondary outcome [3] 0 0
Time to Confirmed Response
Timepoint [3] 0 0
From randomization (initiated January 2010) until December 30, 2010.
Secondary outcome [4] 0 0
Time to Treatment Failure
Timepoint [4] 0 0
approximately 3 years
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [5] 0 0
From randomization (initiated January 2010) until December 30, 2010.
Secondary outcome [6] 0 0
Pre and Post-dose Plasma Vemurafenib Concentration by Study Day
Timepoint [6] 0 0
Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).

Eligibility
Key inclusion criteria
* adults, >/=18 years of age
* metastatic melanoma, stage IIIC or IV (AJCC)
* treatment-naïve (no prior systemic anticancer therapy)
* positive for BRAF V600E mutation
* measurable disease by RECIST criteria
* negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* active central nervous system metastases
* history of carcinomatous meningitis
* severe cardiovascular disease within 6 months prior to study drug administration
* previous malignancy within 5 years prior to study, except for basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix

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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
675
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Frankston
Recruitment hospital [3] 0 0
- Malvern
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Nedlands
Recruitment hospital [6] 0 0
- Newcastle
Recruitment hospital [7] 0 0
- St Leonards
Recruitment hospital [8] 0 0
- Sydney
Recruitment hospital [9] 0 0
- Westmead
Recruitment hospital [10] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3002 - Melbourne
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
2310 - Newcastle
Recruitment postcode(s) [8] 0 0
2065 - St Leonards
Recruitment postcode(s) [9] 0 0
2060 - Sydney
Recruitment postcode(s) [10] 0 0
2145 - Westmead
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
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United States of America
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Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
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United States of America
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Massachusetts
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United States of America
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Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
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North Carolina
Country [12] 0 0
United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Washington
Country [18] 0 0
Canada
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Alberta
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Canada
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Manitoba
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
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Canada
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Quebec
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France
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Bordeaux
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France
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Lille
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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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Nantes
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France
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Nice
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France
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Paris
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France
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Pierre Benite
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France
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Rouen
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France
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Villejuif
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Germany
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Buxtehude
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Germany
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Dresden
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Germany
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Erfurt
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Jena
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Germany
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Kiel
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Germany
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Koeln
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Minden
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Germany
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Muenchen
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Germany
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Regensburg
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Germany
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Tuebingen
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Germany
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Wuerzburg
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Bari
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Roma
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Italy
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Siena
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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New Zealand
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Auckland
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Palmerston North
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New Zealand
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Wellington
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Sweden
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Linkoeping
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Umeå
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Sweden
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Uppsala
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Switzerland
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Lausanne
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Switzerland
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Zürich
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United Kingdom
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Cambridge
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Northwood
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Nottingham
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Oxford
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United Kingdom
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Southampton
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United Kingdom
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Sutton
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United Kingdom
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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/NCT01006980