NCT01774851

A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach

Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With Trastuzumab in Patients With HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone

Detailed description

This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.

Conditions

• HER-2 Gene Amplification
• Esophagus Cancer
• Gastroesophageal Junction Cancer
• Stomach Cancer

Interventions

Type	Name	Description
DRUG	MM-111	MM-111 (IV)
DRUG	Paclitaxel	Paclitaxel (IV)
DRUG	Trastuzumab	Trastuzumab (IV)

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-07-01
• Completion: 2015-12-01
• First posted: 2013-01-24
• Last updated: 2017-06-22
• Results posted: 2017-06-22

Locations

21 sites across 1 country: United States