1200.74: BIBW 2992 in metastatic colorectal cancer

• Research type

  Research Study

• Full title

  An open label, partially randomised Phase II trial to investigate the efficacy and safety of BIBW 2992 in patients with metastatic colorectal cancer who never received prior anti-EGFR treatment

• IRAS ID

  42140

• Contact name

  Tamas Hickish

• Eudract number

  2009-011996-59

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a partially randomised, open label study to investigate the efficacy and safety of a new drug, BIBW 2992, in patients with advanced colorectal cancer who have not previously been treated with a class of drugs known as EGFR (Epidermal Growth Factor Receptor) inhibitors and who have failed standard chemotherapy. Before starting study treatment, samples of the patient's tumour will be tested for mutations (spontaneous changes) in a particular gene called KRAS. Patients who do not have mutations in the KRAS gene will be randomised to receive either BIBW 2992 (Arm A) or cetuximab (Arm B). Patients who do have mutations on the KRAS gene will all receive BIBW 2992 (Arm C).

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/34

• Date of REC Opinion

  13 May 2010

• REC opinion

  Further Information Favourable Opinion