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 have 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 are on concurrent therapy with other anti-neoplastic agents.

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

Other protocol-defined inclusion/exclusion criteria may apply