NCT01304797

Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive Breast Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	MM-302 Monotherapy	Escalating doses of MM-302 as a single agent
DRUG	MM-302 in combination with trastuzumab	Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
DRUG	MM-302 in combination with trastuzumab q3w	Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
DRUG	MM-302 in combination with trastuzumab and cyclophosphamide	Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab and cyclophosphamide is fixed at an every 3 week dosing schedule

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-08-01
• Completion: 2017-01-01
• First posted: 2011-02-25
• Last updated: 2017-01-06

Locations

5 sites across 1 country: United States