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A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Not Recruiting
Trial ID: NCT01774851
Purpose
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more
effective than paclitaxel and trastuzumab alone
Official Title
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
Eligibility
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
Intervention(s):
drug: MM-111
drug: Paclitaxel
drug: Trastuzumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061