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NCT00939627 · ClinicalTrials.gov registry record · Phase 2

Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
55
Enrollment target

NCT00939627: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00939627 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00939627, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
55 participants
Enrollment target

Study Summary

Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cetuximab is more effective when given alone or together with sorafenib tosylate in treating patients with head and neck cancer. This randomized phase II trial is studying cetuximab to see how well it works when given together with or without sorafenib tosylate in treating patients with refractory, recurrent, and/or metastatic head and neck cancer.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER placebo
  • PROCEDURE quality-of-life assessment
  • BIOLOGICAL cetuximab
  • DRUG sorafenib tosylate

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2009-07
Est. Completion 2014-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00939627

The ClinicalTrials.gov registry entry for NCT00939627 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 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 5 interventions - of which laboratory biomarker analysis is the first listed.

NCT00939627 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00939627 about?

NCT00939627 is a clinical study titled "Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab". Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some o...

What is the current status of trial NCT00939627?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2009-07. Estimated completion is 2014-01.

What interventions are being tested in trial NCT00939627?

The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), quality-of-life assessment (PROCEDURE), cetuximab (BIOLOGICAL), sorafenib tosylate (DRUG).

Who is sponsoring clinical trial NCT00939627?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.