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

Stopped early · Phase 2

Conditions studied: HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer

In brief

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

Key facts

Study ID

NCT01774851

Run by

Merrimack Pharmaceuticals

People needed

84

Starts

2013-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Stanford, California, United States
• Study site — Denver, Colorado, United States
• Study site — Ocala, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Urbana, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Buffalo, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Wenatchee, Washington, United States

Full record on ClinicalTrials.gov

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