Phase Ib trial of Atu027 in HNSCC
Research type
Research Study
Full title
Phase Ib trial of Atu027 in Combination With Cisplatin, 5-FU and Cetuximab in Patients With Head and Neck Cancer.
IRAS ID
137199
Contact name
Anna Rowe
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2013-004701-83
Duration of Study in the UK
1 years, 9 months, 24 days
Research summary
The main purpose of this trial is to determine what dose of a new drug, Atu027, is safe and tolerable to use in combination with the standard chemotherapy for the treatment of head and neck cancer.
Cisplatin, 5-FU and Cetuximab are the current standard treatment for this type of cancer. Atu027 has not been used in this cancer before and is a new type of drug called a small interfering RNA.
Atu027 acts in a way that is thought to play an important role in the movement and development of metastasis in cancer (the spreading of cancer).
Research has shown that Atu027 may work better when given with other cancer drugs, so it will be given along with standard treatment.
Patients will receive Atu027 on a weekly basis, with the others being given in their usual manner (Cisplatin every 3 weeks, 5-FU over 4 days every 3 weeks, and Cetuximab every week).
Blood and tissue samples will be taken, at various time points, so that we can see what the body does to the Atu027, and what Atu027 does to the body.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/0118
Date of REC Opinion
13 Jun 2014
REC opinion
Further Information Favourable Opinion