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Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC) — VISMONEO  

Basal Cell Carcinoma Clinical Trial

Official title:
Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)

Clinical Trial Summary

Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.

Clinical Trial Description

Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg (in accordance with the product SmPC) per administration. One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance. The trial will consist of a Screening Period (Day -28 to -1), a Treatment Period (Day 1 to BOR), one End of Treatment Visit, one Surgery Visit and 8 Safety Follow-Up Visits after the last dose of Vismodegib (+/- 5 days). Day 1 of the study will be defined as the first day a patient receives Vismodegib. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02667574
Study type Interventional
Source University Hospital, Lille
Contact
Status Completed
Phase Phase 2
Start date November 18, 2014
Completion date July 15, 2020
View Details
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