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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
In the dose escalation phase, subjects will receive a single oral dose of RDEA119 on Day 1, wait 1 week, then begin a 28-day course of daily continuous dosing of RDEA119. In the expanded MTD phase, subjects will receive RDEA119 once or twice a day beginning on Day 1, and begin a 28-day course of continuous dosing at that time.
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States
UCHSC
Aurora, Colorado, United States
Roswell Park Cancer
Buffalo, New York, United States
Safety will be assessed as adverse and drug related events, clinical laboratory test results (hematology, chemistry, coagulation, and urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examination
Time frame: 35 Days
Pharmacokinetics and Pharmacodynamics
Time frame: 35 Days
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