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NCT00879385 · ClinicalTrials.gov registry record · Phase 1
KRAS Wild-type Metastatic Colorectal Cancer Trial
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00879385: Completed Phase 1 study, sponsored by University of Utah.
NCT00879385 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00879385, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
OBJECTIVES: Primary Objectives 1.To evaluate the safety and feasibility of the sequential use of a DNA methyltransferase (DNMT) inhibitor (decitabine) with a targeted biological agent against EGFR (panitumumab) for KRAS wild type tumors in the second or third line treatment of advanced metastatic colorectal cancer. Secondary Objectives 1. To examine re-expression or a reduction in promoter methylation in genes involved in tumor suppressor pathways known to be important in colorectal cancer (CRC) or involved in EGFR signaling pathway. 2. Evaluate overall response (OR = CR +PR) according to RECIST criteria at 2, 4, and 6 cycles. Progression free survival, measured as the first evidence of tumor growth from the start of treatment will also be assessed. 3. Measure CEA levels at the beginning of each cycle to examine if they correlate with treatment response or disease progression.
Interventions
- DRUG Dacogen™ (decitabine)
- DRUG Vectibix® (panitumumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT00879385 record still lists
NCT00879385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Dacogen™ (decitabine) is the first listed.
NCT00879385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00879385 about?
NCT00879385 is a clinical study titled "KRAS Wild-type Metastatic Colorectal Cancer Trial". OBJECTIVES: Primary Objectives 1.To evaluate the safety and feasibility of the sequential use of a DNA methyltransferase (DNMT) inhibitor (decitabine) with a targeted biological agent against EGFR (panitumumab) for KRAS wild type tumors in the second or third line treatment of advanced metastatic ...
What is the current status of trial NCT00879385?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2009-12. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00879385?
The interventions under investigation include: Dacogen™ (decitabine) (DRUG), Vectibix® (panitumumab) (DRUG).
Who is sponsoring clinical trial NCT00879385?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00879385's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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