Phase II study of MEHD7945A in Patients with Head and Neck Cancer

• Research type

  Research Study

• Full title

  A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF MEHD7945A VERSUS CETUXIMAB IN PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE PROGRESSED DURING OR FOLLOWING PLATINUM BASED CHEMOTHERAPY

• IRAS ID

  109819

• Contact name

  Christopher Nutting

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2011-005539-22

• ISRCTN Number

  n/a

• Research summary

  An estimated 644,000 new cases of head and neck cancer are diagnosed each year worldwide, posing the sixth leading cause of cancer death. More than 95% of head and neck cancers are a type known as squamous cell carcinoma (SCCHN). The incidence of SCCHN has increased steadily during the last several decades. To date, patients with recurrent/metastatic SCCHN continue to have limited treatment options and poor outcome. The purpose of this study is to find out what effects, good and/or bad, the study drug (MEHD7945A) has on recurrent/metastatic SCCHN. Patient will be treated with either MEHD7945A or cetuximab and will know what treatment they receive. 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 stop cancer growth. Cetuximab is a compound that causes the inhibition of tumour growth, invasion and metastasis. Cetuximab is approved in Europe and the United States for use in combination with radiotherapy in locally advanced SCCHN and in combination with chemotherapy in recurrent/metatstic SCCHN. 110 patients are expected to take part in the study at 25 to 40 study centres worldwide. Eligible patients will receive an infusion of MEHD7945A every 2 weeks or an infusion of cetuximab once a week. Patients treated with cetuximab will have the option to switch to MEHD7945A if their tumour grows, provided that they continue to meet the eligibility criteria. Participants will be able to continue taking MEHD7945A or cetuximab until the study is terminated or until their cancer progresses or if the patient experiences intolerable side effects. 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 - Harrow Research Ethics Committee

• REC reference

  12/LO/1282

• Date of REC Opinion

  22 Oct 2012

• REC opinion

  Further Information Favourable Opinion