A Study of MM-111 and Paclitaxel With or Without Trastuzumab in Patients HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach

Status: Recruiting
Phase:
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01774851 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-196

 

To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone for group 1 and to determine whether the combination of MM-111 plus paclitaxel is more effective than paclitaxel alone for group 2.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
David P. Ryan, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

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 as follows - 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
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