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NCT02436408 · ClinicalTrials.gov registry record · Phase 4
VISmodegib for ORbital and Periocular Basal Cell Carcinoma
A Phase 4 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT02436408: Completed Phase 4 study, sponsored by University of Michigan Rogel Cancer Center.
NCT02436408 is a Phase 4 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02436408, a Phase 4 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care. Patients with tumors that do not respond to treatment with Vismodegib, and those who have a good response but poor tolerance of Vismodegib, will be offered surgical excision of the tumor. Patients with a good response and good tolerance of Vismodegib may continue the treatment as long as clinically indicated.
Primary Outcome
The VAWS was developed for the purpose of this study. It is made up of standard ophthalmic exam points, as well as subjective assessment of tearing and overall patient satisfaction. The maximum score is 50 and a score of 21 or greater will be considered a good outcome.
Interventions
- DRUG Vismodegib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-07-15 |
| Est. Completion | 2020-09 |
| Phase | Phase 4 |
What the finished NCT02436408 record still lists
NCT02436408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Vismodegib is the first listed.
NCT02436408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02436408 about?
NCT02436408 is a clinical study titled "VISmodegib for ORbital and Periocular Basal Cell Carcinoma". Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway a...
What is the current status of trial NCT02436408?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2015-07-15. Estimated completion is 2020-09.
What interventions are being tested in trial NCT02436408?
The interventions under investigation include: Vismodegib (DRUG).
Who is sponsoring clinical trial NCT02436408?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02436408's enrollment target sits among peer trials
35 1506th of 2000 higher than 481 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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