NCT01304784

A Study of MM-111 in Combination With Multiple Treatments in Patients With HER2 Positive Cancer

A Phase 1 and Pharmacologic Study of MM-111 in Combination With Multiple Treatment Regimens in Patients With Advanced HER2 Positive Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, dose-escalation study of MM-111 with five different combination treatments with the main goal of determining the safety of MM-111 with each combination.

Detailed description

To determine the MTD and any DLT of MM 111 when administered in combination with either 1) cisplatin, capecitabine, and trastuzumab; 2) lapatinib +/- trastuzumab; 3) paclitaxel and trastuzumab 4) lapatinib, paclitaxel and trastuzumab or 5) docetaxel and trastuzumab in patients with human epidermal growth factor receptor (HER2+) solid tumors

Conditions

• HER-2 Gene Amplification

Interventions

Type	Name	Description
DRUG	Cisplatin, Capecitabine, Trastuzumab and MM-111	Conventional chemotherapy
DRUG	Lapatinib +/- Trastuzumab and MM-111	Conventional chemotherapy
DRUG	Paclitaxel, Trastuzumab and MM-111	Conventional chemotherapy
DRUG	Lapatinib, trastuzumab, paclitaxel, and MM-111	Conventional chemo
DRUG	Docetaxel, trastuzumab and MM-111	Conventional chemotherapy

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2011-02-25
• Last updated: 2015-12-16

Locations

15 sites across 1 country: United States