Conditions: HER-2 Gene Amplification Esophagus Cancer Gastroesophageal Junction Cancer Stomach Cancer
Keywords: HER-2 Gene Amplification Esophagus Cancer Gastroesophageal Junction Cancer Stomach Cancer Her2 Positive Her2+ Esophageal Cancer Metastatic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

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

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.

Arms:
arm 1: MM-111 + Paclitaxel + Trastuzumab arm 2: Paclitaxel + Trastuzumab

Interventions: intervention 1: MM-111 intervention 2: Paclitaxel intervention 3: Trastuzumab
Intervention descriptions: intervention 1: MM-111 (IV) intervention 2: Paclitaxel (IV) intervention 3: Trastuzumab (IV)

Protocol document: