CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 127 enrolled
Drug / intervention
Dabrafenib +1 moredrug
Likely dose
Dabrafenib 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02039947
NCT02039947Phase 2Completed
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BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

Novartis Pharmaceuticals·interventional·Posted Jan 20, 2014·Updated May 21, 2019

In Brief

A Phase 2 clinical trial evaluating Dabrafenib and Trametinib for Melanoma and Brain Metastases. Completed, enrolled 127 participants across 47 sites in 7 countries.

Detailed Summary

This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma and Brain Metastases
CountriesAustralia, Canada, France, Germany, Italy, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 20, 2014
Enrollment StartFeb 21, 2014
Primary CompletionMay 12, 2017
Study CompletionFeb 14, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.5 years ago

Interventions

Dabrafenibdrug

Dabrafenib will be provided as 50 mg and 75 mg capsules

Trametinibdrug

Trametinib will be provided as 0.5 mg and 2.0 mg tablets