NCT01394939

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

A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Jennerex Biotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.

Detailed description

This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)

Conditions

• Colorectal Carcinoma
• CRC

Interventions

Type	Name	Description
BIOLOGICAL	JX-594	Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
DRUG	Irinotecan	180 mg/m2 IV every 2 weeks.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-06-01
• Completion: 2015-10-01
• First posted: 2011-07-15
• Last updated: 2021-01-08
• Results posted: 2021-01-08

Locations

11 sites across 3 countries: United States, Canada, France

Regulatory

• FDA-regulated drug study