MedTrace Logo

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

NCT01394939 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-01-08

Study results available
· View outcomes & findings →

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.

Conditions

  • Colorectal Carcinoma
  • CRC

Interventions

BIOLOGICAL

JX-594

Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

DRUG

Irinotecan

180 mg/m2 IV every 2 weeks.

Sponsors & Collaborators

  • Transgene

    collaborator INDUSTRY

  • Jennerex Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • James Burke, MD · Jennerex Biotherapeutics

  • Derek Jonker, MD · Ottawa Hospital and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-06-30
Completion
2015-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394939 on ClinicalTrials.gov