NCT01520389

Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.

Detailed description

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified, and subsequently in combination with irinotecan. The study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 + irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will participate.

Conditions

• Advanced Solid Tumors
• Colorectal Cancer
• Squamous Cell Head and Neck Cancer
• Non Small Cell Lung Cancer
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	MM-151	MM-151
DRUG	MM-151 + irinotecan	MM-151 + irinotecan

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2012-01-30
• Last updated: 2018-03-21

Locations

4 sites across 1 country: United States