A Clinical Trial to Investigate Biomarker Effects in HNSCC Patients
Research type
Research Study
Full title
A Clinical Trial to investigate biomarker effects of pre-surgical treatment with DDR agents in patients with Head and Neck Squamous Cell Carcinoma (HNSCC) who are planned to undergo surgery that is likely to be followed by radiotherapy and/or chemotherapy
IRAS ID
217826
Contact name
Manojkumar Satyavarapu
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-003115-35
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Squamous cell carcinoma is the most frequent tumour of the head and neck region. Head and Neck Squamous Cell Carcinoma(HNSCC) usually develops in males.The male to-female ratio is 2:1.The five year survival rate of patients with HNSCC is about 40-50%.
Cells in the body divide and grow in an orderly way;however in cancer important proteins which help control cell growth behave abnormally,leading to faster cell growth and uncontrolled multiplication.
The research compounds (AZD6738 or olaparib) to be evaluated in this study have the potential to inhibit the growth of cancer cells by interfering in the way cancer cells divide.In doing so, they might stimulate the patient’s immune system,if this occurs, the research compounds might be used in future in combination with other anti-cancer agents.
This study is not to treat participants’ cancer, but to collect data that may help future studies. This study looks at the differences which might indicate a stimulation of the immune system in participants with HNSCC that are scheduled to have surgery which is likely to be followed by radiotherapy and/or chemotherapy.
This is a blinded randomised study,meaning that each participant will be assigned AZD6738 or olaparib randomly,and that neither the participant or study doctor will know which treatment is initially assigned.Once the treatment has been assigned both the participant and study doctor will be informed of the specific study medication being taken.
Participants will receive one of the research compounds for between 9 and 21 days and will then have their surgery.A biopsy will need to be provided if the surgery is planned beyond 12 days of starting on the treatment.AstraZeneca is sponsoring this study which will take place across the USA and Europe.Approximately 40 participants will be recruited.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0324
Date of REC Opinion
30 Nov 2018
REC opinion
Further Information Favourable Opinion