Trial · NCT02366312
A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors
NCT02366312, Phase 2, Completed, NYU College of Dentistry; results first posted 2021-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors. Trials, record NCT02366312. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02366312
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors
- NCT number
- NCT02366312
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- NYU College of Dentistry
- Conditions
- Keratocystic Odontogenic Tumor
- Interventions
- vismodegib
- First posted
- 2015-02-19
- Last updated
- 2021-02-18
- Results first posted
- 2021-02-18
- Limitations and caveats
- Enrollment for the study closed early by the sponsor due to low enrollment number. Only two subjects were enrolled and received the study treatment.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | KCOT Volume (Greatest Dimension) | Baseline, 6 month (in treatment), 1 year (in treatment), 2 Year (post-treatment), 3 Year (post-treatment) | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | KCOT Volume (Greatest Dimension) | Baseline, 6 month (in treatment), 1 year (in treatment), 2 Year (post-treatment), 3 Year (post-treatment) | Subjects received ERIVEDGE® (vismodegib) 150 mg capsule orally once daily for 12 months. | centimeter | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| KCOT Volume (Greatest Dimension) | NBCCS-associated KCOT | Baseline | 3 | centimeter | |
| KCOT Volume (Greatest Dimension) | Sporadic KCOT | Baseline | 3.8 | centimeter | |
| KCOT Volume (Greatest Dimension) | NBCCS-associated KCOT | 6 month (In treatment) | 0 | centimeter | |
| KCOT Volume (Greatest Dimension) | Sporadic KCOT | 6 month (In treatment) | 2.6 | centimeter | |
| KCOT Volume (Greatest Dimension) | NBCCS-associated KCOT | 1 Year (In treatment) | 2.3 | centimeter | |
| KCOT Volume (Greatest Dimension) | Sporadic KCOT | 1 Year (In treatment) | 2.0 | centimeter | |
| KCOT Volume (Greatest Dimension) | NBCCS-associated KCOT | 2 Year (post-treatment) | 2.2 | centimeter | |
| KCOT Volume (Greatest Dimension) | Sporadic KCOT | 2 Year (post-treatment) | 1.9 | centimeter | |
| KCOT Volume (Greatest Dimension) | NBCCS-associated KCOT | 3 Year (post-treatment) | 2.0 | centimeter | |
| KCOT Volume (Greatest Dimension) | Sporadic KCOT | 3 Year (post-treatment) | 0 | centimeter |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NBCCS-associated KCOT | 1 | |
| Overall Study | STARTED | Sporadic KCOT | 1 | |
| Overall Study | COMPLETED | NBCCS-associated KCOT | 1 | |
| Overall Study | COMPLETED | Sporadic KCOT | 0 | |
| Overall Study | NOT COMPLETED | NBCCS-associated KCOT | 0 | |
| Overall Study | NOT COMPLETED | Sporadic KCOT | 1 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain | General disorders | NBCCS-associated KCOT | 0 | 1 | 0 |
| other | Pain | General disorders | Sporadic KCOT | 1 | 1 | 1 |
| other | Earache | Ear and labyrinth disorders | NBCCS-associated KCOT | 0 | 1 | 0 |
| other | Earache | Ear and labyrinth disorders | Sporadic KCOT | 1 | 1 | 1 |
| other | Sore Throat | General disorders | NBCCS-associated KCOT | 0 | 1 | 0 |
| other | Sore Throat | General disorders | Sporadic KCOT | 1 | 1 | 1 |
| other | Cramping | Musculoskeletal and connective tissue disorders | NBCCS-associated KCOT | 0 | 1 | 0 |
| other | Cramping | Musculoskeletal and connective tissue disorders | Sporadic KCOT | 1 | 1 | 1 |
| other | spasm | Musculoskeletal and connective tissue disorders | NBCCS-associated KCOT | 1 | 1 | 1 |
| other | spasm | Musculoskeletal and connective tissue disorders | Sporadic KCOT | 0 | 1 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NBCCS-associated KCOT | 0 | 1 |
| Total, all-cause mortality | Sporadic KCOT | 0 | 1 |
| Total, other adverse events | NBCCS-associated KCOT | 1 | 1 |
| Total, other adverse events | Sporadic KCOT | 1 | 1 |
| Total, serious adverse events | NBCCS-associated KCOT | 0 | 1 |
| Total, serious adverse events | Sporadic KCOT | 1 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NBCCS-associated KCOT vs Sporadic KCOT: deaths from any cause | Trial comparisons |
| NBCCS-associated KCOT vs Sporadic KCOT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02366312
GET https://conductscience.org/api/trials/v1/NCT02366312/events?page=2