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A Phase I Trial of Single Agent Trametinib (GSK1120212) in Advanced Cancer Patients with Hepatic Dysfunction
The purpose of this study is to test the safety of trametinib at different doses in patients with cancer who have different degrees of abnormal liver function to find out what effects, if any, it has on people.
Primary Objectives: To provide appropriate dosing recommendations for patients with varying degree of hepatic dysfunction receiving trametinib (mild, moderate and severe). To establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction. To characterize the PK profile of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction. Secondary Objectives: To document the non-DLTs associated with the administration of trametinib in patients with varying degrees of hepatic dysfunction. To document any antitumor activity associated with trametinib treatment of patients enrolled on this study. To explore and characterize predictive biomarkers for individual cancer patients utilizing genomic sequencing technologies.