NCT01380600

Safety Study of Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma

A Phase 1b Dose Escalation Study of JX-594 (Thymidine Kinase-Inactivated Vaccinia Virus Plus GM-CSF) Administered by Biweekly (Every Two Weeks) Intravenous Infusion in Patients With Metastatic, Refractory Colorectal Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Jennerex Biotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously every 2 weeks in colorectal carcinoma patients who are refractory to or intolerant of oxaliplatin, irinotecan, and Erbitux treatments.

Conditions

• Carcinoma, Colorectal

Interventions

Type	Name	Description
DRUG	Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)	Intravenous Dose Range: 1x10\^6 pfu/kg, 1x10\^7 pfu/kg, 3x10\^7 pfu/kg Up to 4 intravenous infusions administered over 60 minutes every 2 weeks.

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-11-01
• Completion: 2015-12-01
• First posted: 2011-06-27
• Last updated: 2016-01-08

Locations

1 site across 1 country: South Korea