Trastuzumab Emtansine (T-DM1) 2nd line Metastatic Gastric Study

• Research type

  Research Study

• Full title

  A randomised, multicenter, adaptive phase II-III study to evaluate the efficacy and safety of trastuzumb 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

• IRAS ID

  99751

• Contact name

  Wasat Mansoor

• Sponsor organisation

  F Hoffman-La Roche

• Eudract number

  2012-000660-22

• Research summary

  At present, locally advanced or metastatic Gastric Cancer (GC) remains an incurable disease, with the main aim of treatment to maximise patient??s survival and quality of life. This study aims to determine whether trastuzumab emtansine (TDM-1) is effective in previously treated patients, with HER2-positive locally advanced or metastatic GC, when compared to current available drug treatment with taxanes. The study will also look at side effects and safety of the drug in these GC patients. A total of approximately 412 patients will be recruited into the study globally. There will be 3 treatment groups. Which treatment each patient gets, T-DM1 or a taxane, will be decided by chance by a computer, not by the doctor. The study will look at two doses of TDM-1. The first group of patients will receive TDM-1, intravenously every 3 weeks, the second group of patients will receive a different dose of TDM-1 intravenously once weekly. The third group of patients will receive docetaxel every 3 weeks or paclitaxel once weekly. Approximately 300 (70%) patients will receive TDM-1. Drug treatment will continue until the patient??s disease progresses (worsens), the patient starts a different drug treatment, there is unacceptable toxicity, or the patient or study doctor decides to stop treatment. The study will continue for approximately 3 years. In the UK it is expected that 16 patients will be enrolled at 6 participating study centres. The study is sponsored by F. Hoffman-La Roche Ltd.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0585

• Date of REC Opinion

  22 Aug 2012

• REC opinion

  Favourable Opinion