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Brief Title: Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
Official Title: 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.
Study ID: NCT01394939
Brief 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)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Scottsdale, Arizona, United States
UCSD Moores Cancer Center, La Jolla, California, United States
Billings Clinic Cancer Center, Billings, Montana, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Ottawa Hospital and Research Institute (OHRI), Ottawa, Ontario, Canada
Hôpital Saint Antoine, Paris, , France
Hôpital Hautepierre, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Name: James Burke, MD
Affiliation: Jennerex Biotherapeutics
Role: STUDY_DIRECTOR
Name: Derek Jonker, MD
Affiliation: Ottawa Hospital and Research Institute
Role: PRINCIPAL_INVESTIGATOR