Ramucirumab in Metastatic Gastric Adenocarcinoma

• Research type

  Research Study

• Full title

  A Randomised, Multicentre, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

• IRAS ID

  60241

• Contact name

  David Cunningham

• Sponsor organisation

  ImClone LLC

• Eudract number

  2010-020426-18

• ISRCTN Number

  Not known

• Research summary

  Stomach cancer (gastric adenocarcinoma) is a major cause of cancer-related death worldwide, and although removal (via surgical resection) is the preferred treatment method, approximately two thirds of patients are not eligible for surgery because the disease is too advanced or has spread to other areas of the body (metastatic disease). The life expectancy for such patients is approximately 3 to 5 months in median. At present, systemic chemotherapy is the mainstay of treatment for metastatic stomach cancer because patients may benefit in terms of improved quality of life and a prolonged life expectancy (9-11 months in median). At present, there’s no standard treatment for patients whose tumour continues to grow during or after discontinuation of chemotherapy. However, several chemotherapeutic as well as so called “targeted” agents (specific proteins called monoclonal antibodies or small molecules) have shown promising anti-tumour activity in Phase I-II clinical trials. Meanwhile, some of these chemotherapeutic agents like paclitaxel are frequently used in clinical practice to treat patients whose stomach cancer has failed to previous standard chemotherapy. In the body, formation of blood vessels is a normal process (angiogenesis). However, some growth factors, in particular one called vascular endothelial growth factor (VEGF), have been shown to contribute to abnormal angiogenesis, assisting in tumour growth. VEGF expression in stomach cancer is associated with more aggressive forms of the disease. For patients that have had the tumour removed, VEGF is also associated with recurrence and shorter survival. The study drug (ramucirumab) is a monoclonal antibody, which prevents VEGF action and thereby may improve the effectiveness of chemotherapy. The proposed study is investigating whether ramucirumab can improve the effectiveness of paclitaxel (a chemotherapy drug) in patients with metastatic stomach cancer that had progressed under previous treatment with a standard chemotherapy, as measured by prolonged overall survival time. This is a randomised, double-blind, placebo-controlled trial which means that neither the study doctor nor the patient will know which medication is being given and patients will be randomly assigned to one of the two treatment arms; • Arm A (experimental arm) - paclitaxel + ramucirumab • Arm B (control arm) • paclitaxel + placebo (a dummy drug, containing no active medicine) This is a multicentre study which will take place at 200 sites across 30 countries globally. It is anticipated that approximately 663 patients will be enrolled, about 30 of those from the UK.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/167

• Date of REC Opinion

  7 Mar 2011

• REC opinion

  Further Information Favourable Opinion