A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors

Novartis Pharmaceuticals3 sites in 2 countries103 target enrollmentMarch 2009

ConditionsAdvanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma

InterventionsLDE225

DrugsLDE225

Overview

Phase: Phase 1
Intervention: LDE225
Conditions: Advanced Solid Tumor Cancers
Sponsor: Novartis Pharmaceuticals
Enrollment: 103
Locations: 3
Primary Endpoint: determine maximum tolerated dose of single agent LDE225
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

July 2013

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

LDE225

Intervention: LDE225

Outcomes

Primary Outcomes

determine maximum tolerated dose of single agent LDE225

Time Frame: 28 day cycles

Secondary Outcomes

assess preliminary anti-tumor activity(every other 28-day cycle)
characterize safety and tolerability(28 day cycles)
characterize pharmacokinetics (PK) of single and repeated doses of LDE225(28 day cycles)