An East Asian Study of LDE225
Phase 1
Completed
- Conditions
- Advanced Solid Tumor CancersMedulloblastomaBasal Cell Carcinoma
- Interventions
- Registration Number
- NCT01208831
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LDE225 LDE225 -
- Primary Outcome Measures
Name Time Method determine maximum tolerated dose of single agent LDE225 28 day cycles
- Secondary Outcome Measures
Name Time Method characterize safety and tolerability 28 day cycles characterize pharmacokinetics (PK) of single and repeated doses of LDE225 28 day cycles assess preliminary anti-tumor activity 28 day cycles
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇳Taipei, Taiwan