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Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer

NCT00719199 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-10-22

No results posted yet for this study

Summary

Open-label phase 1b trial. Study treatment will be administered in 3 week cycles.

There are two distinct parts in this study:

* Part 1: Dose escalation from IMO-2055
* Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored

Conditions

Interventions

DRUG

IMO-2055

SC weekly injections

DRUG

Cetuximab

given weekly through intravenous administration. Cycle 1 Day 1 dose given at 400mg/m2, all subsequent doses given at 250 mg/m2.

DRUG

FOLFIRI

Given day 1 of each cycle

Sponsors & Collaborators

Principal Investigators

  • Phil Breitfeld, MD · EMD Serono

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-04-30
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00719199 on ClinicalTrials.gov