Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02436408
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2015-05-01
Brief Title:
VISmodegib for ORbital and Periocular Basal Cell Carcinoma
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
VISmodegib for ORbital and Periocular Basal Cell Carcinoma VISORB
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISORB
Brief 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM00082579 | OTHER | University of Michigan | None |