Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-12 @ 5:51 AM
Study NCT ID:
NCT02067104
Status:
TERMINATED
Last Update Posted:
2019-08-14
First Post:
2014-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
A Placebo Controlled Double-Blind Study to Evaluate the Efficacy of Vismodegib as Chemoprevention of New Bcc Development in High Risk Subjects
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC).
Detailed Description:
The primary objective of this study will be to determine if vismodegib pulse therapy will significantly reduce the incidence of newly diagnosed basal cell carcinomas (BCC) in high risk individuals when compared with placebo, as measured by the incidence of biopsy confirmed BCC over a 24 month period.
The secondary objective will be to determine that there will be no difference in the incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving vismodegib treatment when compared with placebo, as measured by the incidence of biopsy confirmed SCC over the same 24 month period.
The secondary objective will be to determine that there will be no difference in the incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving vismodegib treatment when compared with placebo, as measured by the incidence of biopsy confirmed SCC over the same 24 month period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ML28585 | OTHER | Genentech BioOncology | View |