A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
NCT ID: NCT01774851
Last Updated: 2017-06-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
84 participants
INTERVENTIONAL
2013-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1a
MM-111 + Paclitaxel + Trastuzumab
MM-111
MM-111 (IV)
Paclitaxel
Paclitaxel (IV)
Trastuzumab
Trastuzumab (IV)
Arm 1b
Paclitaxel + Trastuzumab
Paclitaxel
Paclitaxel (IV)
Trastuzumab
Trastuzumab (IV)
Interventions
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MM-111
MM-111 (IV)
Paclitaxel
Paclitaxel (IV)
Trastuzumab
Trastuzumab (IV)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merrimack Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Akos Czibere, MD, PhD
Role: STUDY_DIRECTOR
Merrimack Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
Los Angeles, California, United States
Stanford, California, United States
Denver, Colorado, United States
Ocala, Florida, United States
St. Petersburg, Florida, United States
Urbana, Illinois, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Buffalo, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Wenatchee, Washington, United States
Countries
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Other Identifiers
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MM-111-13-02-04
Identifier Type: -
Identifier Source: org_study_id
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