NCT01451632

A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

A Phase 1 Study of MM-121 in Combination With Cetuximab and Irinotecan in Patients With Advanced Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.

Detailed description

This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 plus cetuximab plus irinotecan. The study assessed the safety, tolerability, and pharmacokinetics of MM-121, cetuximab and irinotecan.

Conditions

• Colorectal Cancer
• Squamous Cell Head and Neck Cancer
• Non-small Cell Lung Cancer
• Triple Negative Breast Cancer
• Other Tumors With EGFR Dependence

Interventions

Type	Name	Description
DRUG	MM-121	escalating doses MM-121 IV QW
DRUG	Irinotecan	180 mg/m2 IV Q2W
DRUG	Cetuximab	escalating doses cetuximab IV QW

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-11-01
• Completion: 2014-06-01
• First posted: 2011-10-13
• Last updated: 2016-09-08
• Results posted: 2016-09-08

Locations

4 sites across 1 country: United States