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NCT02366312 · ClinicalTrials.gov registry record · Phase 2
A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors
A Phase 2 study of Keratocystic Odontogenic Tumor, sponsored by NYU College of Dentistry.
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT02366312: Completed Phase 2 study of Keratocystic Odontogenic Tumor, sponsored by NYU College of Dentistry.
NCT02366312 is a Phase 2 study of Keratocystic Odontogenic Tumor that has completed, run by NYU College of Dentistry. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02366312, a Phase 2 study of Keratocystic Odontogenic Tumor, has completed, sponsored by NYU College of Dentistry.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine how well a daily dose of 150 mg of Erivedge (vismodegib) reduces Keratocystic odontogenic tumor (KCOT) size, and to evaluate the safety of this dose. Erivedge is FDA-approved for use in adults with a specific type of skin cancer. However, the drug is experimental for patients with KCOT.
Primary Outcome
To evaluate the efficacy of GDC-0449 in reducing KCOT size (shrinkage) in NBCCS-associated KCOT and sporadic KCOT patients following 6 to 12 months of ingestion of 150 mg/day, up to 1 year of treatment and up to 2 years of post- treatment follow-up.
Conditions Studied
Interventions
- DRUG vismodegib
Study Locations (1)
New York
- NYU Bluestone Center For Cllinical Research - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-10-27 |
| Est. Completion | 2019-08 |
| Phase | Phase 2 |
What the finished NCT02366312 record still lists
NCT02366312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Keratocystic Odontogenic Tumor appearing as the primary indexed condition, and to 1 intervention - of which vismodegib is the first listed.
NCT02366312 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02366312 about?
NCT02366312 is a clinical study titled "A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors". The purpose of this study is to determine how well a daily dose of 150 mg of Erivedge (vismodegib) reduces Keratocystic odontogenic tumor (KCOT) size, and to evaluate the safety of this dose. Erivedge is FDA-approved for use in adults with a specific type of skin cancer. However, the drug is experim...
What is the current status of trial NCT02366312?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2015-10-27. Estimated completion is 2019-08.
What conditions does trial NCT02366312 study?
This clinical trial studies the following conditions: Keratocystic Odontogenic Tumor.
What interventions are being tested in trial NCT02366312?
The interventions under investigation include: vismodegib (DRUG).
Who is sponsoring clinical trial NCT02366312?
This trial is sponsored by NYU College of Dentistry, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02366312 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02366312's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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