CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
vismodegibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02366312
NCT02366312Phase 2Completed
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A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors

NYU College of Dentistry·interventional·Posted Feb 19, 2015·Updated Feb 18, 2021

In Brief

A Phase 2 clinical trial evaluating vismodegib for Keratocystic Odontogenic Tumor. Completed, enrolled 2 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratocystic Odontogenic Tumor
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 19, 2015
Enrollment StartOct 27, 2015
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.4 years ago

Interventions

vismodegibdrug

vismodegib is a synthetic, small molecule inhibitor of the sonic Hh pathway, which is involved in tumorigenesis, thus providing a strong rationale for its use in the treatment of a variety of cancers.