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

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Basal Cell Carcinoma

Interventions: vismodegib

Countries: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

* Concurrent anti-tumor therapy
* Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment
* Uncontrolled medical illness

Locations (181)

Buenos Aires, Argentina
Kogarah, New South Wales, Australia
Westmead, New South Wales, Australia
Adelaide, South Australia, Australia
Carlton, Victoria, Australia
Graz, Austria
Salzburg, Austria
Sankt Pölten, Austria
Vienna, Austria
Leuven, Belgium
Banja Luka, Bosnia and Herzegovina
Sarajevo, Bosnia and Herzegovina
Porto Alegre, Rio Grande do Sul, Brazil
Barretos, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Plovdiv, Bulgaria
Sofia, Bulgaria
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Canada
Bogotá, Colombia
Bogotá, Colombia
Cali, Colombia
Medellin-Antioquia, Colombia
Medellín, Colombia
Zagreb, Croatia
České Budějovice, Czechia
+ 151 more on CT.gov