NCT00734305

Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

A Phase I and Pharmocologic Study of MM-121 in Patients With Refractory Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design to determine maximum tolerated dose/recommended Phase 2 dose.

Detailed description

Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 2 dose was identified. The study initially explored a dosing schedule every 7-days, which may have been modified to longer intervals under certain circumstances but did not expand to more than weekly. When the maximum tolerated dose/recommended Phase 2 dose was identified, an Expansion Cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints. There were 3 sites that participated.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	MM-121	Dose escalation Frequency - once weekly

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-05-01
• Completion: 2013-09-01
• First posted: 2008-08-14
• Last updated: 2016-09-01
• Results posted: 2016-09-01

Locations

3 sites across 1 country: United States