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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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