Spots Global Cancer Trial Database for An Absorption, Distribution, Metabolism and Excretion (ADME) Study of Single Oral Dose [14C] GSK2118436 in Subjects With BRAF Mutant Solid Tumors

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Trial Identification

Brief Title: An Absorption, Distribution, Metabolism and Excretion (ADME) Study of Single Oral Dose [14C] GSK2118436 in Subjects With BRAF Mutant Solid Tumors

Official Title: An Open-Label Study to Characterize the Absorption, Distribution, Metabolism and Elimination of a Single Oral 14C Labeled Dose of GSK2118436 in Subjects With BRAF Mutant Solid Tumors

Study ID: NCT01262963

Conditions

Cancer

Interventions

GSK2118436

Study Description

Brief Summary: The study is a Phase 1, open-label study designed to characterize the absorption, distribution, metabolism and excretion of GSK2118436 following administration of a single oral 14C labeled dose of GSK2118436 as a suspension in subjects with BRAF mutation positive tumors.

Detailed Description: GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. The study is a Phase 1, open-label study designed to characterize the absorption, distribution, metabolism and excretion of GSK2118436 following administration of a single oral 14C labeled dose of GSK2118436 as a suspension in subjects with BRAF mutation positive tumors. A sufficient number of subjects will be enrolled to complete approximately four subjects. Following completion of the study, subjects may continue dosing with GSK2118436 in the rollover study, BRF114144.