NCT02039947

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma and Brain Metastases

Interventions

Type	Name	Description
DRUG	Dabrafenib	Dabrafenib will be provided as 50 mg and 75 mg capsules
DRUG	Trametinib	Trametinib will be provided as 0.5 mg and 2.0 mg tablets

Timeline

• Start date: 2014-02-21
• Primary completion: 2017-05-12
• Completion: 2018-02-14
• First posted: 2014-01-20
• Last updated: 2019-05-21
• Results posted: 2019-05-21

Locations

47 sites across 7 countries: United States, Australia, Canada, France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study