IMC1121B and Best Supportive Care-Metastatic Gastric Adenocarcinoma

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy

• IRAS ID

  30827

• Contact name

  Ian Chau

• Sponsor organisation

  ImClone LLC

• Eudract number

  2008-005964-15

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to evaluate the effects of IMC-1121B, the investigational drug, with best supportive care (following disease progression on first line platinum or Fluorpyrimidine-containing combination therapy) in patients with gastric cancer. This research study is open to patients with gastric cancer (including adenocarcinomas of the Gastroesophageal junction) that has spread to Other areas of the body and that has not responded to treatment. This study will include up to 615 patients and will be conducted in about 250 centers worldwide. All patients who participate in this research study will be divided into two areas. Patients will be assigned to each arm randomly. One arm will receive IMC-1121B plus best supportive care (BSC) and the other arm will receive Placebo (dummy drug) plus best supportive care (BSC). All subjects will be randomly assigned to IMC-1121B and Placebo in a 2:1 ratio.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  10/H0801/6

• Date of REC Opinion

  9 Feb 2010

• REC opinion

  Favourable Opinion