NCT00423410

A Safety Study of EPC2407, A Anti-Cancer Drug With Vascular Disrupting Activity: In Patients With Advanced Cancer

A First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: EpiCept Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic effects of a novel anti-cancer drug, EPC2407, administered to patients with advanced cancer which have not responded to or have recurred following treatment with available therapies

Detailed description

This is a Phase I, open label, multicenter, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study of EPC2407 administered intravenously over 60 minutes on a QDx3 schedule repeated every 21 days. Patients are enrolled and dosed at the level defined by the escalation scheme. The primary goal of the study design is to assess toxicity at the fixed dose levels according to the modified Fibonacci schema.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	EPC2407 (crinobulin)	IV infusion 1 to 4 hours

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-04-01
• Completion: 2009-09-01
• First posted: 2007-01-18
• Last updated: 2009-09-10

Locations

3 sites across 1 country: United States