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NCT01641939 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer (NCT01641939)

Trial Description
This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) compared to standard taxane treatment in patients with HER2-positive advanced gastric cancer. At the start of the trial, patients will be randomized to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 mg/kg every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg every week; Arm C: standard taxane therapy (docetaxel or paclitaxel per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected. The regimen selection analysis will be made after approximately 100 patients across all three study arms have been treated for at least 4 cycles (12 weeks).

Once a trastuzumab emtansine regimen has been selected, Stage I patients who were assigned to the treatment arm which was selected for Stage II of the study and patients who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I patients who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional patients will be recruited and randomized to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Patients will receive study treatment until disease progression, unacceptable toxicity or withdrawal.

This trial is sponsored by  F. Hoffmann-La Roche. [1]

Study Data

  • Condition: Gastric Cancer
  • Interventions:
    • Drugs used in this trial
  • Phase: III
  • Estimated Enrollment: 412
  • Start: September 2012
  • Estimated Completion: December 2016
  • Last verified: July 2015

Study Schematic

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Last Editorial review: July 28, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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