A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Inclusion Criteria:

   - For patients with mBCC, histologic confirmation of distant BCC metastasis

   - For patients with locally advanced BCC, at least one histologically confirmed lesion
   10 mm or more in diameter and written confirmation from a surgical specialist that the
   tumor is considered inoperable or that surgery is contraindicated

   - For patients with locally advanced BCC, radiotherapy must have been previously
   administered for locally advanced BCC, unless radiotherapy is contraindicated or
   inappropriate. For patients whose locally advanced BCC has been irradiated, disease
   must have progressed after radiation.

   - Patients with Gorlin syndrome may enroll in this study but must meet the criteria for
   locally advanced or metastatic disease listed above

   - Patients with measurable and/or non-measurable disease (as defined by RECIST) are
   allowed

   - Adequate organ function

   - For women of childbearing potential, agreement to the use of two acceptable methods of
   contraception, including one barrier method, during the study and for 12 months after
   discontinuation of Vismodegib (GDC-0449)

   - For men with female partners of childbearing potential, agreement to use a latex
   condom, and to advise their female partner to use an additional method of
   contraception during the study and for 3 months after discontinuation of Vismodegib
   (GDC-0449)

Exclusion Criteria:

   - Pregnancy or lactation

   - Life expectancy < 12 weeks

   - Concurrent non-protocol-specified anti-tumor therapy

   - Completion of most recent anti-tumor therapy at least 21 days prior to initiation of
   treatment

   - Uncontrolled medical illnesses such as infection requiring treatment with intravenous
   antibiotics

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

   - Unwillingness to practice effective birth control