A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma
Both
Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma
Trial Information
A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
determine maximum tolerated dose of single agent LDE225
Outcome Time Frame:
28 day cycles
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CLDE225X2101
NCT ID:
NCT00880308
Start Date:
March 2009
Completion Date:
December 2013
Related Keywords:
- Advanced Solid Tumor Cancers
- Medulloblastoma
- Basal Cell Carcinoma
- Advanced tumors
- hedgehog
- smoothened inhibitor
- Carcinoma
- Carcinoma, Basal Cell
- Medulloblastoma
- Neoplasms
Name | Location |
|---|---|
| University of Pittsburgh Medical Center SC | Pittsburgh, Pennsylvania |
| Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) | San Antonio, Texas 78229 |
