A Phase II, Multicenter, Open-Label, Three-Cohort Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma (BCC)

Inclusion Criteria:

- Confirmed new (not recurrent or previously treated) nodular BCC at one of the listed
anatomical sites, which must be biopsy confirmed at the study site

- Willingness to consent to biopsy of the lesion

- Willingness to delay excision of the target tumor site until the time mandated in the
protocol, unless evidence of disease progression or lack of drug tolerability

- Adequate hematopoietic capacity

- Adequate hepatic function

- For women of childbearing potential, agreement to use two acceptable forms of birth
control (including one barrier method) during the study and for 7 months after
discontinuation of study drug

- For men with female partners of childbearing potential, agreement to use a male
condom (with spermicide) and to advise their female partners to use an additional
acceptable method of birth control during the study and for 2 months after
discontinuation of study drug

- Agreement not to donate blood/blood products during the study and for 7 months after
discontinuing study drug

- Agreement not to donate sperm or semen during treatment and for 2 months after the
last dose of vismodegib

Exclusion Criteria:

- Prior treatment with vismodegib or any Hedgehog pathway inhibitor

- Inability or unwillingness to swallow capsules

- Pregnancy or lactation

- BCC with any clinical and histological pattern other than nodular BCC

- Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical
suspicion of Gorlin's syndrome

- Recent (i.e., within the past 28 days), current, or planned participation in another
experimental drug study

- Use of any excluded medication or therapy within 21 days of study entry

- History of other malignancies within 3 years of Day 1, except for tumors with a
negligible risk of metastasis such as other non-melanoma skin cancer (BCC, squamous
cell cancer), ductal carcinoma in situ of the breast, carcinoma in situ of the cervix

- Uncontrolled medical illness

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect
interpretation of the results of the study or renders the patient at high risk for
treatment complications

- Any medical or psychological illness or condition preventing adequate consent