Advanced Solid Tumor Cancers, Basal Cell Carcinoma, Medulloblastoma
Conditions
Keywords
Advanced tumors, hedgehog, smoothened inhibitor
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 Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.
Interventions
DRUGLDE225
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| determine maximum tolerated dose of single agent LDE225 | 28 day cycles |
Secondary
| Measure | Time frame |
|---|---|
| characterize safety and tolerability | 28 day cycles |
| characterize pharmacokinetics (PK) of single and repeated doses of LDE225 | 28 day cycles |
| assess preliminary anti-tumor activity | 28 day cycles |
Countries
Hong Kong, Japan, Taiwan
Outcome results
None listed