Clinical trial · Interventional
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors
NCT01106508CI-TRIAL-00048899completedPhase 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 LEQ506 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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Locally Advanced or Metastatic Basal Cell Carcinoma | — | UNRESOLVED | — |
| Recurrent or Refractory Medulloblastoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LEQ506 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LEQ506
- interventionNames
- Drug: LEQ506
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
- timeFrame
- 21 day cycles
Secondary outcomes (4)
- measure
- To characterize the safety and tolerability of LEQ506 treatment
- timeFrame
- 21 day cycles
- measure
- To characterize the pharmacokinetics of LEQ506
- timeFrame
- 21 day cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma) * Protocol defined laboratory parameters * Performance status ≤ 2 * Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy Exclusion Criteria: * History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients) * Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea * Impairment of cardiac function or significant cardiac disease * Pregnant or lactating women * Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.