Clinical trial · Interventional
An East Asian Study of LDE225
An East Asian Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
NCT01208831CI-TRIAL-00048975completedPhase 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)
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.
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 (1)
- DERIVEDMinami H, Ando Y, Ma BB, Hsiang Lee J, Momota H, Fujiwara Y, Li L, Fukino K, Ito K, Tajima T, Mori A, Lin CC. Phase I, multicenter, open-label, dose-escalation study of sonidegib in Asian patients with advanced solid tumors. Cancer Sci. 2016 Oct;107(10):1477-1483. doi: 10.1111/cas.13022. Epub 2016 Sep 24. PMID 27467121