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NCT01334177 · ClinicalTrials.gov registry record · Phase 1
TLR8 Agonist VTX-2337 and Cetuximab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Squamous Cell Cancer of Head and Neck
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01334177: Completed Phase 1 study, sponsored by University of Washington.
NCT01334177 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01334177, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when given together with cetuximab in treating patients with locally advanced, recurrent, or metastatic squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. 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. Giving TLR8 Agonist VTX-2337 together with cetuximab may kill more tumor cells.
Primary Outcome
Frequency and severity of hematologic and non-hematologic adverse events will be compiled for each dose cohort. Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0), duration, seriousness, and relatedness; and clinically significant laboratory abnormalities.
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL cetuximab
- OTHER pharmacogenomic studies
- DRUG TLR8 agonist VTX-2337
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-06 |
| Phase | Phase 1 |
What the finished NCT01334177 record still lists
NCT01334177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01334177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01334177 about?
NCT01334177 is a clinical study titled "TLR8 Agonist VTX-2337 and Cetuximab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Squamous Cell Cancer of Head and Neck". This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when given together with cetuximab in treating patients with locally advanced, recurrent, or metastatic squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as TLR8 Agonist VTX-2337 may stimul...
What is the current status of trial NCT01334177?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-06.
What interventions are being tested in trial NCT01334177?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cetuximab (BIOLOGICAL), pharmacogenomic studies (OTHER), TLR8 agonist VTX-2337 (DRUG).
Who is sponsoring clinical trial NCT01334177?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01334177's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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