Spots Global Cancer Trial Database for A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma
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Trial Identification
Brief Title: A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma
Official Title: A Phase II, Multicenter, Open-label, Three-cohort Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma (BCC)
Study ID: NCT01201915
Conditions
Interventions
Study Description
Brief Summary: This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent) operable basal cell carcinoma of the nodular subtype.
Detailed Description: For Cohort 1, the response to treatment was determined at the end of the 12 weeks of treatment. For Cohort 2, the response to treatment was determined after 12 weeks of treatment and 24 weeks of observation. For Cohort 3, the response to treatment was determined after intermittent dosing over a 20-week period, consisting of an initial 8-week treatment period, followed by a 4-week drug holiday period, followed by a second 8-week treatment period.
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Scottsdale, Arizona, United States
, Los Angeles, California, United States
, Redwood City, California, United States
, San Diego, California, United States
, St. Petersburg, Florida, United States
, Alpharetta, Georgia, United States
, Chicago, Illinois, United States
, Louisville, Kentucky, United States
, Philadelphia, Pennsylvania, United States
, Bartlett, Tennessee, United States
, Houston, Texas, United States
, Madison, Wisconsin, United States
Contact Details
Name: Ivor Caro, M.D.
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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