An East Asian Study of LDE225

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.

• 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