Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
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