Clinical trial · Interventional
Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors
A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
NCT00880308CI-TRIAL-00048946completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor Cancers | — | UNRESOLVED | — |
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LDE225 | Drug | Sonidegib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LDE225
- interventionNames
- Drug: LDE225
Primary outcomes (1)
- measure
- determine maximum tolerated dose of single agent LDE225
- timeFrame
- 28 day cycles
Secondary outcomes (3)
- measure
- characterize safety and tolerability
- timeFrame
- 28 day cycles
- measure
- characterize pharmacokinetics (PK) of single and repeated doses of LDE225
- timeFrame
- 28 day cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.