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

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merrimack Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach

• Patients must have documentation of histologically or cytologically confirmed HER2 expression

• Patients must be ≥18 years of age

• Patients must have ECOG PS of 0, 1, or 2

• Patients must have adequate hematologic status, renal and hepatic function

Exclusion Criteria:

• Patients with known hypersensitivity to any of the components of MM-111

• Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL

• Patients with a known history of hypersensitivity to trastuzumab or any of its components (group 1 patients only)

• Patients with an active infection or with an unexplained fever >38.5°C