Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00610194
Brief 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
Study:
NCT00610194
Study Brief:
Protocol Section:
NCT00610194