Clinical Trial VICCGI1283

Title

A Randomized, Multicenter, Adaptive Phase II/III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel or Paclitaxel) in Patients with Previously Treated Locally Advanced or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma of the Gastroesophageal Junction

Principal Investigator(s)

Dana Cardin

Details

  • Protocol No. VICCGI1283
  • Open Date: 02/14/2013
  • Staging: Phase II/III
  • Age Group: Adults
  • Scope: National
  • Objective: Phase II/III - To select a trastuzumab emtansine dose and schedule for Phase III assessment of treatment for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC), defined as locally advanced or unresectable or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ) on the basis of safety, pharmacokinetics, and efficacy Phase III - To compare the overall survival (OS) of patients treated with trastuzumab emtansine at the dose and schedule selected in the Phase II portion of the study
  • Disease Sites: Gastric/Gastroesophageal
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Docetaxel; Docetaxel (Taxotere); Paclitaxel; Trastuzumab emtansine (T-DM1)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01641939
  • Secondary Protocol No: B027952

Description

Eligibility

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