An East Asian Study of LDE225
Status and phase
Completed
Phase 1
Conditions
Medulloblastoma
Advanced Solid Tumor Cancers
Basal Cell Carcinoma
Treatments
Drug: LDE225
Details and patient eligibility
About
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.
Enrollment
45 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
45 participants in 1 patient group
LDE225
Experimental group
Treatment:
Drug: LDE225
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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