NCT00719199

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

Open-label Phase 1b Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer Who Have Progressed Following Chemotherapy for Advanced or Metastatic Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

* Part 1: Dose escalation of IMO-2055, including 3 dose groups. Once a recommended phase 2 dosage (RP2D) of IMO-2055 given concomitantly with FOLFIRI and cetuximab is found the selected cohort will be expanded by an additional 6 to 9 patients (to a total of 12 patients) for confirmation of the RP2D and combination treatment regimen. * Part 2: A final cohort of 12 patients (Cohort 6) will be enrolled simultaneously to explore tolerability and pharmacodynamics in patients treated with the RP2D of IMO-2055 in combination with FOLFIRI with cetuximab.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-04-01
• Completion: 2011-08-01
• First posted: 2008-07-21
• Last updated: 2013-10-22

Locations

5 sites across 1 country: United States