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

June 19, 2017 updated by: Merrimack Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrimack Pharmaceuticals

Investigators

  • Study Director: Akos Czibere, MD, PhD, Merrimack Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-111-13-02-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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