drugset / Trial / NCT00505713

Safety and Efficacy Study Using Rexin-G for Sarcoma

NCT00505713 ↗

Phase 1/2 Completed 36 enrolled Epeius Biotechnologies
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Rexin-G is a tumor-targeted (pathotropic or disease-seeking) nanoparticle that when injected intravenously, seeks out and accumulates in cancerous lesions, thus enhancing local drug concentration within tumors. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

Timeline

Start
2007-07
Primary completion
2010-07
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexin-G Unknown 1e+11 unknown Intravenous
Subject Rexin-G Unknown 2e+11 unknown Intravenous
Subject Rexin-G Unknown 3e+11 unknown Intravenous
Subject Rexin-G Unknown 4e+11 unknown Intravenous

Indications