NCT01367665

STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,232 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	vismodegib	150 mg once daily until disease progression or unacceptable toxicity

Timeline

• Start date: 2011-07-01
• Primary completion: 2017-06-14
• Completion: 2017-06-14
• First posted: 2011-06-07
• Last updated: 2019-06-06
• Results posted: 2019-06-06

Locations

181 sites across 37 countries: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom