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NCT00326495 · ClinicalTrials.gov registry record · Phase 2
BAY 43-9006 Plus Cetuximab to Treat Colorectal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT00326495: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00326495 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00326495, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
Background: * Colorectal cancer (CRC) is a major public health problem in the U.S. and worldwide, and 5-year survival with widespread metastatic disease is less than 5%. * Expression of epidermal growth factor receptor (EGFR) or up-regulation of the gene occurs in the majority of CRC cases (60-80%). * Therapies targeting EGFR, like cetuximab, have shown activity in the treatment of solid tumors like CRC. * Cetuximab is FDA (Food and Drug Administration) approved for the treatment of EGFR-expressing CRC, but clinical responses to cetuximab are seen in only 10% of EGFR-expressing CRC. * One possible mechanism of resistance to cetuximab could be KRAS (Kirsten rat sarcoma) mutations. * Another major pathway implicated in colon carcinogenesis is the vascular endothelial growth factor (VEGF) pathway, which is involved in angiogenesis and is a validated target for therapy in CRC. * BAY 43-9006 is both a Raf kinase inhibitor and an inhibitor of VEGF receptor (VEGFR2) tyrosine kinase. * We hypothesize that the combined inhibition of EGFR, VEGFR2, and the Ras-(rapidly accelerated fibrosarcoma) Raf pathway will demonstrate promising clinical activity in CRC. Furthermore, in patients with mutant KRAS, combination of cetuximab with a drug that inhibits Raf kinase and acts downstream of Ras mutations, could restore tumor sensitivity to cetuximab. Objectives: * To determine the rate of response (complete response (CR) + partial response (PR) + stable disease (SD) for 4 months) and toxicity profile of combination of BAY 43-9006 and cetuximab in previously treated EGFR-expressing metastatic CRC in patients with mutant KRAS. * To evaluate BAY 43-9006 pharmacokinetics \& pharmacogenomics (CYP3A4/5 (cytochrome P450 3A4/5)). * To evaluate for this combination treatment pharmacodynamics, effect on tumor vascularity and effect on angiogenic cytokines. Eligibility: * Adults with histologically or cytologically documented, measurable, EGFR-expressing metastatic CRC, which has recurred
Interventions
- DRUG Cetuximab
- DRUG BAY 43-9006
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2006-05-10 |
| Est. Completion | 2014-11-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00326495
The ClinicalTrials.gov registry entry for NCT00326495 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT00326495 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00326495 about?
NCT00326495 is a clinical study titled "BAY 43-9006 Plus Cetuximab to Treat Colorectal Cancer". Background: * Colorectal cancer (CRC) is a major public health problem in the U.S. and worldwide, and 5-year survival with widespread metastatic disease is less than 5%. * Expression of epidermal growth factor receptor (EGFR) or up-regulation of the gene occurs in the majority of CRC cases (60-80%)...
What is the current status of trial NCT00326495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2006-05-10. Estimated completion is 2014-11-07.
What interventions are being tested in trial NCT00326495?
The interventions under investigation include: Cetuximab (DRUG), BAY 43-9006 (DRUG).
Who is sponsoring clinical trial NCT00326495?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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