Status:
COMPLETED
Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumor Cancers
Medulloblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- confirmed diagnosis of advanced solid tumor (including •medulloblastoma and basal cell carcinoma)
- blood work criteria
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00880308
Start Date
March 1 2009
End Date
July 1 2013
Last Update
December 19 2020
Active Locations (5)
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1
University of Pittsburgh Medical Center SC
Pittsburgh, Pennsylvania, United States, 15213
2
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
San Antonio, Texas, United States, 78229
3
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08035
4
Novartis Investigative Site
Zurich, Switzerland, 8091