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

• Status: Completed
• Trial end date: 2018-06-29
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.