Phase II study of FOLFIRI+MEHD7945A in metastatic colorectal cancer

• Research type

  Research Study

• Full title

  A PHASE II, MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF FOLFIRI+MEHD7945AVERSUS FOLFIRI+CETUXIMAB IN SECOND LINE IN PATIENTS WITH KRAS WILD-TYPE METASTATIC COLORECTAL CANCER

• IRAS ID

  109034

• Contact name

  John Bridgewater

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2011-005547-27

• ISRCTN Number

  not issused

• Research summary

  Colorectal cancer is the third most commonly diagnosed cancer in males and the second in females. Significant advances in the treatment of metastatic colorectal cancer have been achieved with combination treatments consisting of standard chemotherapy, including flurouracil (5-FU) and folinic acid (leucovorin), and either irinotecan or oxaliplatin. The purpose of this study is to compare the effects, good and/or bad, of two different treatments for colorectal cancer: either MEHD7945A (the study drug) with FOLFIRI (a combination of drugs that includes leucovorin, flurouracil (5-FU), and irinotecan) or Cetuximab with FOLFIRI. Cetuximab and FOLFIRI are drugs that are commonly used for colorectal cancer. MEHD7945A is a compound that targets key proteins essential for the survival and growth of the cancer cells. Because of the way it works it may slow down or stop cancer growth. Approximately 120 patients are expected to take part in the study at approximately 60 study centres worldwide. Eligible patients will receive an infusion of MEHD7945A and FOLFIRI once every 2 weeks or an infusion of Cetuximab once a week and FOLFIRI once every 2 weeks. During scheduled visits patients will undergo a number of procedures to confirm safety and determine the effectiveness of the study drug, including: physical examination, ECG, vital signs, tumour assessment and blood sample collection for laboratory tests.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/1468

• Date of REC Opinion

  3 Jan 2013

• REC opinion

  Further Information Favourable Opinion