Advanced Solid Tumor Cancers, Basal Cell Carcinoma, Medulloblastoma
Conditions
Keywords
Advanced tumors, hedgehog, smoothened inhibitor
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 solid tumors.
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 | every other 28-day cycle |
Countries
Spain, Switzerland, United Kingdom, United States
Outcome results
None listed