Spots Global Cancer Trial Database for Absolute Bioavialability of GSK1120212

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Absolute Bioavialability of GSK1120212

Official Title: Determination of the Absolute Bioavailability of GSK1120212 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microdose of GSK1120212 in Subjects With Solid Tumors

Study ID: NCT01416337

Conditions

Cancer

Interventions

GSK1120212

GSK1120212B

Study Description

Brief Summary: A Phase I, single-center, open-label, single-persiod, combined single dose oral and IV microtracer study in subjects with solid tumors.

Detailed Description: This Phase I, open-label, non-randomized study is designed to determine the absolute bioavailability of the standard 2 mg tablet formulation of GSK1120212 co-administered with an intravenous microdose (5 μg) dose of \[14C\]-labelled GSK1120212 (7.4 kBq) in subjects with solid tumors. Pharmacokinetic sampleswill be obtained up to 10 days post-dose. Safety assessments, including assessment of adverse events, clinical laboratory values (hematology and clinical chemistry) and vital signs, will be performed throughout the study. After completing all assessments, eligible subjects may transition to MEK114375, an open-label, rollover study to continue treatment with GSK1120212.