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

Phase 2

Terminated

• Conditions: HER-2 Gene Amplification; Gastroesophageal Junction Cancer; Esophagus Cancer; Stomach Cancer
• Interventions: Drug: MM-111; Drug: Paclitaxel; Drug: Trastuzumab

• Registration Number: NCT01774851
• Lead Sponsor: Merrimack Pharmaceuticals

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-24
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Results First Submitted: 2017-05-10
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Results First Posted: 2017-06-22
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1a	Trastuzumab	MM-111 + Paclitaxel + Trastuzumab
Arm 1b	Trastuzumab	Paclitaxel + Trastuzumab
Arm 1a	MM-111	MM-111 + Paclitaxel + Trastuzumab
Arm 1a	Paclitaxel	MM-111 + Paclitaxel + Trastuzumab
Arm 1b	Paclitaxel	Paclitaxel + Trastuzumab

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	30 months	Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.