Status:
COMPLETED
An East Asian Study of LDE225
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumor Cancers
Medulloblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Chi...
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 :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01208831
Start Date
October 1 2010
End Date
October 1 2013
Last Update
December 19 2020
Active Locations (4)
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1
Novartis Investigative Site
Hong Kong, Hong Kong
2
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 466-8560
3
Novartis Investigative Site
Kobe, Hyōgo, Japan, 650-0017
4
Novartis Investigative Site
Taipei, Taiwan, 10048