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A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Trial ID: NCT01327053
This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.
Phase II, Randomized Double-blind Study of Efficacy and Safety of Two Dose Levels of LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
- Patients with locally advanced BCC and metastatic BCC
- Patients with adequate bone marrow, liver, and renal function
- 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
- 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.
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