CS1008-A-E203

• Research type

  Research Study

• Full title

  A PHASE 2 OPEN-LABEL RANDOMISED TRIAL OF CS-1008 IN COMBINATION WITH IRINOTECAN VS IRINOTECAN ALONE IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA WHO FAILED FIRST LINE OXALIPLATIN BASED CHEMOTHERAPY

• IRAS ID

  20394

• Sponsor organisation

  DAIICHI SANKYO DEVELOPMENT LTD.

• Eudract number

  2007-005675-34

• ISRCTN Number

  n/a

• Research summary

  Second-line treatment for patients with bowel cancer that has spread is usually limited to treatment with a drug called irinotecan. This drug does not give very good shrinkage rates and does not usually hold the tumour at bay for more than 2 or 3 months. In this trial we are attempting to find out whether giving another drug called CS-1008 in combination with irinotecan will increase the length of time that the treatment can hold the tumour at bay to about 4 or 5 months. The CS-1008 drug binds to a special molecule called a receptor on the surface of cancer cells and by doing this, causes the cells to die. It is thought that the CS-1008 might work particularly well with the standard drug irinotecan because irinotecan increases the numbers of these receptors on cancer cells.The first 6-12 patients on the study will all get the irinotecan and the CS-1008 drug but the irinotecan will be given at a slightly reduced dose to make sure the combination is safe and to find out whether we can give irinotecan at full dose in combination with the CS-1008 or whether we will need to decrease the dose a little if there is a lot of extra side effects. However we do not expect this to be the case. Once we are sure it is safe, all subsequent patients will be given a drip of irinotecan once every 3 weeks and half of the patients will also be given a drip of CS-1008 once per week. This is what we call a randomised trial.Between 80 and 92 patients are likely to go on the study and they will be entered from 10 hospitals across the UK.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/73

• Date of REC Opinion

  1 Jul 2009

• REC opinion

  Further Information Favourable Opinion