Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients
Completed · Phase 1
Conditions studied: Advanced Cancer
In brief
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
Key facts
- Study ID
- NCT00610194
- Run by
- Bayer
- People needed
- 69
- Starts
- 2007-11-28
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2023-10-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- TGen Clinical Research Services at Scottsdale Healthcare — Scottsdale, Arizona, United States
- UCHSC — Aurora, Colorado, United States
- Roswell Park Cancer — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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