drugset / Trial / NCT00121745

Evaluation of Safety of Rexin-G Gene Transfer for Advanced Pancreatic Cancer

NCT00121745 ↗

Phase 1 Terminated 12 enrolled Epeius Biotechnologies
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a dose-seeking study that will test the safety of increasing doses of Rexin-G, given intravenously, in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy. Rexin-G is a tumor-targeted gene therapy vector that contains a "killer" gene that blocks the action of the human cyclin G1 gene. Cyclin G1 is a cell cycle control element that plays an important role in cancer growth. When injected into a vein, the Rexin-GTM vector seeks out and accumulates in cancerous tumors, therefore, increasing the concentration of the drug in the cancerous tumors and not in normal neighbouring organs.

Timeline

Start
2005-07
Primary completion
—
Completion
2007-07

Outcome

Outcome not reported

Stopped (Enrollment): “poor enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexin-G Unknown 7.5e+09 unknown Intravenous
Subject Rexin-G Unknown 1.1e+10 unknown Intravenous
Subject Rexin-G Unknown 3e+10 unknown Intravenous
Subject Rexin-G Unknown 8e+10 unknown Intravenous