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

Conditions

• Melanoma and Brain Metastases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dabrafenib — DRUG
  Dabrafenib will be provided as 50 mg and 75 mg capsules
• Trametinib — DRUG
  Trametinib will be provided as 0.5 mg and 2.0 mg tablets

Study Details

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.

Key Dates

First listed

Jan 20, 2014

Start date

Feb 21, 2014

Status verified

May 2019

Primary completion

May 12, 2017

Completion

Feb 14, 2018

Study Design

Enrollment

127 participants (actual)

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A
  Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
• Experimental: Cohort B
  Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
• Experimental: Cohort C
  Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
• Experimental: Cohort D
  Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity

Primary Outcome Measure

Intracranial Response (IR) Rate in Cohort A [ Time Frame: From the start of treatment until disease progression or the start of new anti-cancer therapy ]

Locations (11)

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