Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

April 8, 2014

Primary Completion Date

April 26, 2017

Study Completion Date

April 26, 2017

Conditions
Melanoma and Brain Metastases
Interventions
DRUG

Dabrafenib 150 mg

Dabrafenib will be provided for oral administration as 50 mg and 75 mg capsules. Dabrafenib will be dosed orally with approximately 200 mL of water, twice a day. Dabrafenib should be administered under fasting conditions.

DRUG

Trametinib 2.0 mg

Trametinib study treatment will be provided as 0.5 mg and 2.0 mg tablets. should be taken orally with approximately 200 mL of water under fasting conditions, either one hour before or two hours after a meal.

Trial Locations (3)

2060

GSK Investigational Site, North Sydney

15232

GSK Investigational Site, Pittsburgh

77030

GSK Investigational Site, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01978236 - Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites | Biotech Hunter | Biotech Hunter