An exploratory study to investigate the pharmacodynamics of RO5083945

• Research type

  Research Study

• Full title

  An exploratory, open label multicenter study to investigate pharmacodynamic of RO5083945, a human monoclonal antibody antagonist of Epidermal Growth Factor Receptor (EGFR), compared to cetuximab in patients with operable head and neck squamous cell carcinoma

• IRAS ID

  28522

• Contact name

  James Spicer

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2009-012656-25

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  This research study will look at the impact of a new drug called RO5083945 compared with cetuximab (a drug already on the market) on head and neck tumour biology. The study will evaluate the behavior of these drugs within the body and their mechanism of action on head and neck tumour cells and on the immune system cells (white blood cells). This trial will be performed in head and neck cancer patients during the surgery waiting time. Participants will be allocated to receive either RO5083945 or cetuximab. In addition tissue samples, such as blood, tumour and a small specimen of skin from all the patients in the study will be compared to see if there is a particular group of patients that benefit from these treatments. The study is looking for approximately 35 patients (approximately 25 patients will be treated with R5083945 and approximately 10 with cetuximab) with head and neck cancer. The duration of this study will be approximately two months (approximately 1 month before surgery and a visit 28 days after last dose).

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/85

• Date of REC Opinion

  16 Nov 2009

• REC opinion

  Further Information Favourable Opinion