NCT01447225

Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

Detailed description

This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 in combination with certain anticancer therapies. The dose-escalation portion of the study employed a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of MM-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. Doses of MM-121 and/or the anticancer therapy were escalated until either the MTD is identified or the combination was shown to be tolerable at the highest planned doses.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	MM-121	MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
DRUG	Carboplatin	administered at AUC 6
DRUG	Pemetrexed	administered IV at 500 mg/m2
DRUG	Cabazitaxel	administered IV at 20 mg/m2 or 25 mg/m2
DRUG	Gemcitabine	administered IV at 1000 mg/m2 or 1250 mg/m2

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-11-01
• Completion: 2014-01-01
• First posted: 2011-10-06
• Last updated: 2016-09-14
• Results posted: 2016-09-14

Locations

5 sites across 2 countries: United States, France