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

Purpose

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

Condition	Intervention	Phase
HER-2 Gene Amplification Esophagus Cancer Gastroesophageal Junction Cancer Stomach Cancer	Drug: MM-111 Drug: Paclitaxel Drug: Trastuzumab	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Genes and Gene Therapy

Drug Information available for: Paclitaxel Trastuzumab

Genetic and Rare Diseases Information Center resources: Esophageal Cancer Stomach Carcinoma

U.S. FDA Resources

Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:

Progression Free Survival (PFS) [ Time Frame: 30 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	120
Study Start Date:	January 2013
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774851

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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

St Petersburg, Florida, United States, 33705
United States, Illinois

Urbana, Illinois, United States, 61801
United States, Massachusetts

Boston, Massachusetts, United States, 02114

Boston, Massachusetts, United States, 02111
United States, Minnesota

Rochester, Minnesota, United States, 55905
United States, Missouri

St. 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

No publications provided


Responsible Party:	Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01774851 History of Changes
Other Study ID Numbers:	MM-111-13-02-04
Study First Received:	January 10, 2013
Last Updated:	March 3, 2015
Health Authority:	United States: Food and Drug Administration

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:


Paclitaxel Trastuzumab Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Phytogenic	Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Tubulin Modulators

ClinicalTrials.gov processed this record on March 03, 2015