Advanced Cancer Clinical Trial
Official title:
A Multi-Center Phase 1, Dose-Escalation Trial to Determine the Safety and Pharmacokinetics/Pharmacodynamics of RDEA119, A MEK Inhibitor, in Advanced Cancer Patients
Primary Objective: To evaluate the safety of escalating oral doses of RDEA119, a MEK inhibitor, in advanced cancer patients. Secondary Objectives: - To describe the initial PK of different doses of RDEA119 when given once orally on Day 1 of the study - To describe the PK of different doses of RDEA119 when given orally as continuous dosing. - To examine the inhibition of MEK products (p-ERK), cytokine products, and other protein biomarkers - To expand the MTD dose cohort to evaluate the safety, tolerability and PK/PD of the recommended Phase 2 dose - To explore the presence of genotype, PD markers, cell growth and a marker of apoptosis, in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a minimum of 10 patients in the expanded cohort
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