Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors

This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.

Inclusion Criteria:

• confirmed diagnosis of advanced solid tumor (including •medulloblastoma and basal cell carcinoma)
• blood work criteria

Exclusion Criteria:

• patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
• positive HIV, hepatitis B or C
• impaired intestinal function
• impaired heart function
• pregnant or breast-feeding women

Other protocol-defined inclusion/exclusion criteria may apply