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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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
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Secondary ID [1]
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2009-012293-12
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Secondary ID [2]
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NO25026
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma
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Condition category
Condition code
Cancer
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.
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Timepoint [1]
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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).
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Primary outcome [2]
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Progression-free Survival
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Assessment method [2]
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A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).
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Timepoint [2]
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From randomization (initiated January 2010) to December 30 2010.
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Secondary outcome [1]
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Participants With a Best Overall Response (BOR) of Complete Response or Partial Response
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Assessment method [1]
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BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.
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Timepoint [1]
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From randomization (initiated January 2010) until December 30, 2010
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan-Meier method.
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Timepoint [2]
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From randomization (initiated in January 2010) until December 30, 2010.
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Secondary outcome [3]
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Time to Confirmed Response
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Assessment method [3]
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Time to response was defined as the time from randomization to confirmed response (complete response or partial response).
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Timepoint [3]
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From randomization (initiated January 2010) until December 30, 2010.
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Secondary outcome [4]
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Time to Treatment Failure
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Assessment method [4]
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Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed.
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Timepoint [4]
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approximately 3 years
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Secondary outcome [5]
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Number of Participants With Adverse Events (AEs)
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Assessment method [5]
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The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above.
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Timepoint [5]
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From randomization (initiated January 2010) until December 30, 2010.
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Secondary outcome [6]
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Pre and Post-dose Plasma Vemurafenib Concentration by Study Day
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Assessment method [6]
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The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling.
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Timepoint [6]
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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).
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2015
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Sample size
Target
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Accrual to date
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Final
675
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Brisbane
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- Frankston
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- Malvern
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- Nedlands
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- Westmead
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- Woolloongabba
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment postcode(s) [4]
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3002 - Melbourne
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Recruitment postcode(s) [5]
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3128 - Melbourne
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6009 - Nedlands
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2310 - Newcastle
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Recruitment postcode(s) [8]
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2065 - St Leonards
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Recruitment postcode(s) [9]
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2060 - Sydney
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2145 - Westmead
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Recruitment postcode(s) [11]
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4102 - Woolloongabba
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Recruitment outside Australia
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Sutton
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This randomized, open-label study evaluated the efficacy, safety and tolerability of
vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with
metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally
twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was
continued until disease progression or unacceptable toxicity occurred. The data and safety
monitoring board recommended that patients in the dacarbazine group be allowed to cross over
to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both
overall survival and progression-free survival endpoints had met the prespecified criteria
for statistical significance in favor of vemurafenib.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01006980
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01006980
Download to PDF