A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Trial ID or NCT#
NCT01774851
Status
NOT RECRUITING
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 Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
