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
Description
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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
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California
- Unknown facility, Los Angeles, California, 90089
- Unknown facility, Los Angeles, California, 90095
- Unknown facility, Stanford, California, 94305
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Nevada
- Unknown facility, Las Vegas, Nevada, 89135
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Colorado
- Unknown facility, Denver, Colorado, 80218
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Washington
- Unknown facility, Wenatchee, Washington, 98801
- Unknown facility, Yakima, Washington, 98092
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Minnesota
- Unknown facility, Rochester, Minnesota, 55905
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Missouri
- Unknown facility, St. Louis, Missouri, 63110
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Illinois
- Unknown facility, Urbana, Illinois, 61801
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Tennessee
- Unknown facility, Nashville, Tennessee, 37203
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Alabama
- Unknown facility, Birmingham, Alabama, 35294
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