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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
HER-2 Gene Amplification; Esophagus Cancer; Gastroesophageal Junction Cancer; Stomach Cancer	Drug: MM-111; Drug: Paclitaxel; Drug: Trastuzumab	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	84 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	January 2013
Actual Primary Completion Date :	July 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm 1a; MM-111 + Paclitaxel + Trastuzumab	Drug: MM-111; MM-111 (IV) Drug: Paclitaxel; Paclitaxel (IV) Drug: Trastuzumab; Trastuzumab (IV)
Active Comparator: Arm 1b; Paclitaxel + Trastuzumab	Drug: Paclitaxel; Paclitaxel (IV) Drug: Trastuzumab; Trastuzumab (IV)

Outcome Measures

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Primary Outcome Measures :

1. Progression Free Survival (PFS) [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Los Angeles, California, United States, 90089
Los Angeles, California, United States, 90095
Stanford, California, United States, 94305
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Ocala, Florida, United States, 34471
Saint Petersburg, Florida, United States, 33705
United States, Illinois
Urbana, Illinois, United States, 61801
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02114
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas, Nevada, United States, 89135
United States, New York
Buffalo, New York, United States, 14263
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44106
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Washington
Wenatchee, Washington, United States, 98801

Sponsors and Collaborators

Merrimack Pharmaceuticals

Investigators

Study Director:	Akos Czibere, MD, PhD	Merrimack Pharmaceuticals

More Information

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Responsible Party:	Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01774851 History of Changes
Other Study ID Numbers:	MM-111-13-02-04
First Posted:	January 24, 2013
Results First Posted:	June 22, 2017
Last Update Posted:	June 22, 2017
Last Verified:	June 2017

Keywords provided by Merrimack Pharmaceuticals:

HER-2 Gene Amplification; Esophagus Cancer; Gastroesophageal Junction Cancer; Stomach Cancer	Her2 Positive; Her2+; Esophageal Cancer; Metastatic

Additional relevant MeSH terms:

Stomach Neoplasms; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms	Esophageal Diseases; Paclitaxel; Albumin-Bound Paclitaxel; Trastuzumab; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action