U31287-A-U203: Double Blind Phase 2 Study of Patritumab (U31287).
Research type
Research Study
Full title
Randomized, Placebo-Controlled, Double Blind Phase 2 Study of Patritumab (U3-1287) in Combination with Cetuximab plus Platinum Based Therapy in First Line Setting in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
IRAS ID
188788
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Daiichi Sankyo Inc
Eudract number
2015-002222-40
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
The purpose of this study is to test a study drug called patritumab. Patritumab is a monoclonal antibody that is made in the laboratory to treat cancer. Monoclonal antibodies are proteins made by your body to fight infections and cancer. Patritumab is a ‘targeted therapy’, attacking proteins normally found on cancer cells which encourage tumour growth. Patritumab may work when combined with medications called cetuximab (also known as Erbitux), cisplatin or carboplatin (cisplatin or carboplatin are known as ‘platinum’ medications). Cetuximab, and cisplatin or carboplatin are approved to treat head and neck cancer whereas Patritumab is an investigational drug being studied and has not yet been approved by any national regulatory authorities or by the European Medicines Agency (EMA). Regulatory authorities allow the use of patritumab only in research studies like this one. The combinations of all of these medications are not approved by any national regulatory authorities or the EMA.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1670
Date of REC Opinion
11 Nov 2015
REC opinion
Further Information Favourable Opinion