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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 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 21 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00879385
The ClinicalTrials.gov registry entry for NCT00879385 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dacogen™ (decitabine) is the first listed.
NCT00879385 reports 0 study locations.
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.
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