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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 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 69 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00610194
The ClinicalTrials.gov registry entry for NCT00610194 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RDEA119 is the first listed.
NCT00610194 reports 0 study locations.
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.
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