Inclusion Criteria

Inclusion Criteria

- Histologically documented, incurable, locally advanced or metastatic solid malignancy
that has progressed after first-line and second-line therapy (if there is a
second-line therapy that has been shown to provide clinical benefit); patients with
basal cell carcinoma will be excluded from this study unless they do not qualify for
another open GDC-0449 clinical trial

- For patients with disease that is evaluable by physical examination only, diagnosis
must also include biomarker confirmation

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Documented negative pregnancy test for women of childbearing potential and agreement
to use an effective form of contraception for the duration of the study

- Adequate hematopoietic capacity

- Adequate hepatic function

- Adequate renal function

- At least 3 weeks since last chemotherapy, investigational agent, radiation therapy,
or major surgical procedure and recovery to pre-treatment baseline or stabilization
of all treatment-related toxicities

Exclusion Criteria

- Known, untreated central nervous system (CNS) malignancies or treated brain
metastases that are not radiographically stable for ≥ 3 months

- Active infection requiring intravenous (IV) antibiotics

- Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, or current known active infection with hepatitis

- Any medical condition or diagnosis that would likely impair absorption of an orally
administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis)

- Any other diseases, 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 may affect the
interpretation of the results or renders the patient at high risk from treatment
complications

- Pregnant or lactating

- Treatment with excluded medications, including strong CYP450 inhibitors and inducers