U31287-A-U106
Research type
Research Study
Full title
An open-label, Phase 1b safety evaluation of patritumab (U3-1287) in combination with cetuximab plus platinum-containing therapy in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck
IRAS ID
162129
Contact name
Robert Blakie
Contact email
Sponsor organisation
Daichii Sankyo Development Limited
Eudract number
2014-002445-22
Duration of Study in the UK
years, 7 months, 0 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’, which attacks a protein found mainly on cancer cells to stop their 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. Patritumab is an investigational drug being studied and has not yet been approved by the regulatory authorities such as the The European Medicines Agency (EMA). Regulatory authorities allow the use of patritumab in only research studies like this one. The combinations of all of these medications are not approved by the EMA.
All participants on the study will receive the combination of patritumab, cetuximab and cisplatin or carboplatin. In previous studies (in other types of cancer, like lung cancer), treatment with patritumab alone was well tolerated with manageable side effects.
It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will also show how safe and how well tolerated when these medications are given together.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1737
Date of REC Opinion
27 Nov 2014
REC opinion
Further Information Favourable Opinion