Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Basal Cell CarcinomaAdvanced Solid Tumor CancersMedulloblastoma
- Interventions
- Registration Number
- NCT00880308
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
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 pharmacokinetics (PK) of single and repeated doses of LDE225 28 day cycles assess preliminary anti-tumor activity every other 28-day cycle characterize safety and tolerability 28 day cycles
Trial Locations
- Locations (3)
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
🇺🇸San Antonio, Texas, United States
Novartis Investigative Site
🇬🇧Leicester, United Kingdom
University of Pittsburgh Medical Center SC
🇺🇸Pittsburgh, Pennsylvania, United States