Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients
Public ClinicalTrials.gov record NCT00610194. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00610194
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 69 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2007
- Primary completion
- Nov 23, 2010
- Completion
- Jul 31, 2012
- Last update posted
- Oct 17, 2023
2007 – 2012
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale | Arizona | 85258 | — |
| UCHSC | Aurora | Colorado | 80045 | — |
| Roswell Park Cancer | Buffalo | New York | 14263 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00610194, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 17, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00610194 live on ClinicalTrials.gov.