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

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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