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

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

Detailed Description
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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.

Official Title
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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

Conditions
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HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer

Intervention / Treatment
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* Drug: MM-111
* Drug: Paclitaxel
* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1a<br>MM-111 + Paclitaxel + Trastuzumab | Drug: MM-111<br>* MM-111 (IV)<br>Drug: Paclitaxel<br>* Paclitaxel (IV)<br>Drug: Trastuzumab<br>* Trastuzumab (IV)<br>|
| Active Comparator: Arm 1b<br>Paclitaxel + Trastuzumab | Drug: Paclitaxel<br>* Paclitaxel (IV)<br>Drug: Trastuzumab<br>* Trastuzumab (IV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | 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. | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer, Her2 Positive, Her2+, Esophageal Cancer, Metastatic