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NCT01195922 · ClinicalTrials.gov registry record · Phase 1
Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma
A Phase 1 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01195922: Completed Phase 1 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT01195922 is a Phase 1 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01195922, a Phase 1 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
Background: \- Advanced-stage head and neck cancer (head and neck squamous cell carcinoma \[HNSCC\]) has moderately successful treatment outcomes, usually involving surgery as part of the standard treatment. Researchers are investigating the use of the drug rapamycin to prevent tumor growth in HNSCC, and are interested in using it to treat individuals with HNSCC that has not been treated previously with other drugs, radiation, or surgery. Objectives: \- To evaluate the usefulness of rapamycin in decreasing tumor size prior to surgery for head and neck squamous cell carcinoma. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with advanced head and neck squamous cell carcinoma that has not yet been treated. Design: * Participants will be screened with a physical examination, medical history, blood tests, and imaging studies. * Approximately 1 month before scheduled surgery, participants will begin to receive rapamycin. Participants will take rapamycin once daily for 21 days, followed by a 7-day period without the drug. * During the 21-day rapamycin treatment, participants will have weekly study visits to provide blood and urine samples and have possible tumor biopsies and imaging studies such as x-rays or tumor photographs. Participants will have additional study visits for tests 1 day and 1 week after the end of rapamycin treatment, followed by HNSCC surgery. * Participants will have a final visit to provide blood samples 30 days after surgery. * Participants medical records will be reviewed 1 year after surgery; however, participants will not need to have further study visits at this time.
Interventions
- DRUG Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2010-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01195922 record still lists
NCT01195922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT01195922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01195922 about?
NCT01195922 is a clinical study titled "Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma". Background: \- Advanced-stage head and neck cancer (head and neck squamous cell carcinoma \[HNSCC\]) has moderately successful treatment outcomes, usually involving surgery as part of the standard treatment. Researchers are investigating the use of the drug rapamycin to prevent tumor growth in HNSC...
What is the current status of trial NCT01195922?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2010-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01195922?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT01195922?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01195922's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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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