To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma
Status:
Terminated
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy
and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not
amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).
The recruitment period is expected to be approximately 24 months. The trial will consist of a
Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated
with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24
weeks).
The study will end 14 months after start of treatment of the last patient enrolled and
evaluable according to primary end point.