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NCT02178072 · ClinicalTrials.gov registry record · Phase 1
Window Trial 5-aza in HNSCC, T-tare
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02178072 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 18 participants.
The verdict
NCT02178072, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the activity of 5-azacitidine in patients with Human Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck cancers or head and neck cancer cells cultured in laboratories suggest that treatment with 5-azacitidine increases changes in cancer cells that lead to their death. This study is designed to determine if similar changes occur in cancer cells of patients with head and neck cancer. The study also aims to determine the amount of a specific type of protein, p53 before and after treatment. Research has shown that the p53 protein is associated with anti-tumor activity. Finally, this study is measuring the amount of a specific type of protein called interferon in your tumor tissue. Interferons are proteins made and released by the body in response to pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons allow for communication between cells to trigger the protective defenses of the immune system that remove pathogens (disease causing agents) or tumors.
Interventions
- DRUG 5-Azacitadine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-02-19 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02178072
The ClinicalTrials.gov registry entry for NCT02178072 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 5-Azacitadine is the first listed.
NCT02178072 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02178072 about?
NCT02178072 is a clinical study titled "Window Trial 5-aza in HNSCC, T-tare". The purpose of this study is to assess the activity of 5-azacitidine in patients with Human Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and after treatment with 5-azac...
What is the current status of trial NCT02178072?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-02-19. Estimated completion is 2019-10-23.
What interventions are being tested in trial NCT02178072?
The interventions under investigation include: 5-Azacitadine (DRUG).
Who is sponsoring clinical trial NCT02178072?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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