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

NCT01274624 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-12-19

No results posted yet for this study

Summary

This is a Phase 1 dose-escalation study with three dose levels to determine the maximum tolerated dose of REOLYSIN® combined with FOLFIRI and bevacizumab.

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2018-02-28
Completion
2018-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01274624 on ClinicalTrials.gov