An Open-label, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of GSK2118436 in Japanese Subjects With BRAF V600 Mutation Positive Solid Tumors.
BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan.
This study will be designed to assess safety, tolerability, single and repeat dose PK
profile and preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation
positive solid tumors using continuous daily dosing schedule. Dose escalation of GSK2118436
will be performed according to a standard 3+3 dose-escalation design. GSK2118436 is given
twice a day. However, to characterize the PK of GSK2118436 and its metabolites after
single-dose administration, GSK2118436 will NOT be administrated for a week after the first
administration. GSK2118436 continuous dosing will start after the 168-hour PK sample is
obtained. Subjects may receive study treatment until disease progression, death or an
unacceptable adverse event.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with adverse events as a measure of safety and tolerability
Adverse Events will be graded by the investigator according to the NCI-CTCAE (version 4.0)
First 28 days for Dose-limiting toxicity, Adverse Events for 1 year
GSK Clinical Trials
Japan: Ministry of Health, Labor and Welfare