Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. To provide appropriate dosing recommendations for patients with varying degree of hepatic dysfunction receiving trametinib (mild, moderate and severe). II. To establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of trametinib in advanced cancer patients ...

PRIMARY OBJECTIVES: I. To provide appropriate dosing recommendations for patients with varying degree of hepatic dysfunction receiving trametinib (mild, moderate and severe). II. To establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction. III. To characterize the pharmacokinetic (PK) profile of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction. SECONDARY OBJECTIVES: I. To document the non-DLTs associated with the administration of trametinib in patients with varying degrees of hepatic dysfunction. II. To document any antitumor activity associated with trametinib treatment of patients enrolled on this study. III. To explore and characterize predictive biomarkers for individual cancer patients utilizing genomic sequencing technologies. OUTLINE: This is a dose-escalation study. Patients receive trametinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

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