Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

March 18, 2014

Primary Completion Date

February 23, 2018

Study Completion Date

April 19, 2021

Conditions
CancerMelanoma
Interventions
DRUG

Dabrafenib

Dabrafenib will be provided as 50 mg and 75 mg capsules. Each capsule will contain 50 mg or 75 mg of free base (present as the mesylate salt)

DRUG

Trametinib

Trametinib study medication will be provided as 0.5 mg and 2.0 mg tablets. Each tablet will contain 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)

Trial Locations (13)

100

Novartis Investigative Site, Taipei

333

Novartis Investigative Site, Taoyuan District

807

Novartis Investigative Site, Kaohsiung City

10320

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

90110

Novartis Investigative Site, Songkhla

100036

Novartis Investigative Site, Beijing

310022

Novartis Investigative Site, Hangzhou

510060

Novartis Investigative Site, Guangzhou

650106

Novartis Investigative Site, Kunming

Unknown

Novartis Investigative Site, Tuenmen

110-744

Novartis Investigative Site, Seoul

120-752

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY