Conditions: Basal Cell Carcinoma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

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.

Arms:
arm 1: Participants received vismodegib 150 mg orally daily for 12 weeks. arm 2: Participants received vismodegib 150 mg orally daily for 12 weeks. arm 3: Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.

Interventions: intervention 1: Vismodegib
Intervention descriptions: intervention 1: Vismodegib was supplied in gelatin capsules.

Protocol document: