Study of Trametinib in Advanced Cancer Patients With Hepatic Dysfunction

Official Title

A Phase I Trial of Single Agent Trametinib (GSK1120212) in Advanced Cancer Patients With Hepatic Dysfunction

Summary:

This is a phase 1 study (the first phase in testing a drug, to see how safe the study drug is) to find the best dose of investigational drug trametinib in patients with solid cancers and varying levels of hepatic (liver) dysfunction.

Trial Description

Primary Outcome:

• Best dose (in mg) of trametinib for patients with varying degree of hepatic dysfunction receiving trametinib (mild, moderate and severe)
• Maximum tolerated dose (MTD) (in mg) of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction
• Dose-limiting toxicity (DLT) (in mg) of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction
• Levels of trametinib in the blood of all participants over 24-hours

Secondary Outcome:

• Number of participants that respond to treatment
• Types of molecular aberrations per patient
• Number side effects in patients with normal liver function
• Number side effects in patients with mild liver dysfunction
• Number side effects in patients with moderate liver dysfunction
• Number side effects in patients with severe liver dysfunction

Patients will be separated into the following groups: Group A: Normal hepatic function, Group B: Mild hepatic dysfunction, Group C: Moderate hepatic dysfunction, Group D: Severe hepatic dysfunction Groups of 3-6 patients to take part in each group will receive increasing doses of the study drug to until the best dose of study drug for each hepatic function group is found. Trametinib is an oral drug that works by blocking mitogen-activated extracellular signal regulated kinase (MEK) 1 and MEK 2. MEK1 and MEK2 are important proteins that are needed for the growth of cells. When these proteins are blocked, it is believed that the growth of cancer cells will stop and the cancer cells will then die.

View this trial on ClinicalTrials.gov