A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Inclusion Criteria:

   - Patients with locally advanced BCC and metastatic BCC

   - Patients with adequate bone marrow, liver, and renal function

Exclusion Criteria:

   - Patients who had had major surgery within 4 weeks of initiation of study medication

   - Patients unable to take oral drugs or with lack of physical integrity of the upper
   gastrointestinal tract, or known malabsorption syndromes.

   - Patients with concurrent medical conditions that may interfere or potentially affect
   the interpretation of the study.

   - Patients with neuromuscular disorders or are on concurrent treatment with drugs that
   may cause muscle damage.

   - Patients who were on concurrent therapy with other anti-neoplastic agents.

   - Patients who had taken part in an experimental drug within 4 weeks of initiation of
   study medication.

   - Pregnant or nursing (lactating) women

   - Women of child bearing potential unwilling to use 2 forms of highly effective
   contraception throughout the study and for 3 months after the last treatment

   - Fertile males not willing to use condoms throughout the study and for 3 months after
   the last treatment.

   - Patients who were unwilling or unable to comply with the protocol.