Clinical Trial VICCGI1306

Title

Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with Trastuzumab in Patients with HER2 Positive Carinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy

Principal Investigator(s)

Jordan Berlin

Details

  • Protocol No. VICCGI1306
  • Open Date: 07/11/2013
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the patient Progression Free Survival (PFS) between the experimental and comparator arm of the study in the following defined patient populations: Overall study population and HRG high poplulation comprised of patients with HRG levels at or above the median in archived tumor tissue samples assessed centrallly by RT-PCR.
  • Disease Sites: Gastrointestinal; Esophageal; Gastric/Gastroesophageal
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Herceptin; MM-111; Paclitaxel; Trastuzumab (Herceptin)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01774851
  • Secondary Protocol No: MM-111-13-02-04

Description

Eligibility

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