A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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