Esophageal Cancer Clinical Trial

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

Summary

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

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Full 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.

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Eligibility 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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT01774851

Recruitment Status:

Terminated

Sponsor:

Merrimack Pharmaceuticals

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There are 21 Locations for this study

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Birmingham Alabama, 35294, United States

Los Angeles California, 90089, United States

Los Angeles California, 90095, United States

Stanford California, 94305, United States

Denver Colorado, 80218, United States

Ocala Florida, 34471, United States

Saint Petersburg Florida, 33705, United States

Urbana Illinois, 61801, United States

Boston Massachusetts, 02111, United States

Boston Massachusetts, 02114, United States

Rochester Minnesota, 55905, United States

Saint Louis Missouri, 63110, United States

Las Vegas Nevada, 89135, United States

Buffalo New York, 14263, United States

Durham North Carolina, 27710, United States

Cleveland Ohio, 44106, United States

Columbus Ohio, 43210, United States

Philadelphia Pennsylvania, 19111, United States

Pittsburgh Pennsylvania, 15232, United States

Nashville Tennessee, 37203, United States

Wenatchee Washington, 98801, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT01774851

Recruitment Status:

Terminated

Sponsor:


Merrimack Pharmaceuticals

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