A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors

Novartis Pharmaceuticals3 sites in 2 countries57 target enrollmentOctober 2010

ConditionsAdvanced Solid Tumors Recurrent or Refractory Medulloblastoma Locally Advanced or Metastatic Basal Cell Carcinoma

InterventionsLEQ506

DrugsLEQ506

Overview

Phase: Phase 1
Intervention: LEQ506
Conditions: Advanced Solid Tumors
Sponsor: Novartis Pharmaceuticals
Enrollment: 57
Locations: 3
Primary Endpoint: To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
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 LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

June 2015

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, 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

Arms & Interventions

LEQ506

Intervention: LEQ506

Outcomes

Primary Outcomes

To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506

Time Frame: 21 day cycles

Secondary Outcomes

To characterize the safety and tolerability of LEQ506 treatment(21 day cycles)
To characterize the pharmacokinetics of LEQ506(21 day cycles)
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples(21 day cycles)
Tumor response(every 6 weeks)