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NCT00610194 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT00610194: Completed Phase 1 study, sponsored by Bayer.
NCT00610194 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00610194, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study 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
Interventions
- DRUG RDEA119
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2007-11-28 |
| Est. Completion | 2012-08-01 |
| Phase | Phase 1 |
What the finished NCT00610194 record still lists
NCT00610194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 1 intervention - of which RDEA119 is the first listed.
NCT00610194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00610194 about?
NCT00610194 is a clinical study titled "Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients". 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 RDEA...
What is the current status of trial NCT00610194?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2007-11-28. Estimated completion is 2012-08-01.
What interventions are being tested in trial NCT00610194?
The interventions under investigation include: RDEA119 (DRUG).
Who is sponsoring clinical trial NCT00610194?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00610194's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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