Study of REOLYSIN® in Combination With FOLFIRI and Bevacizumab in FOLFIRI Naive Patients With KRAS Mutant Metastatic Colorectal Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

February 28, 2018

Study Completion Date

November 30, 2018

Conditions
KRAS Mutant Metastatic Colorectal Cancer
Interventions
BIOLOGICAL

REOLYSIN®

1 hour intravenous infusion administered on Days 1, 2, 3, 4, and 5 every 4 weeks.

DRUG

Irinotecan

90-minute intravenous infusion on Day 1 every 2 weeks. Dose levels of 125 mg/m2, 150 mg/m2, 150 mg/m2, 180 mg/m2.

DRUG

Leucovorin

2-hour infusion of 400 mg/m2 on Day 1 every 2 weeks.

DRUG

Fluorouracil (5-FU)

400 mg/m2 intravenous bolus followed by 2400 mg/m2 as a continuous intravenous infusion over 46 hours administered on Day 1 every 2 weeks.

DRUG

Bevacizumab

30, 60 or 90 minute infusion on Day 1 every 2 weeks. Dose level 5 mg/kg.

Trial Locations (2)

10065

New York Presbyterian Hospital/ Weill Cornell Medical College, New York

10461

Montefiore Medical Center/Albert Einstein College of Medicine, The Bronx

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Montefiore Medical Center

OTHER

lead

Oncolytics Biotech

INDUSTRY