IDR-OM-02
Research type
Research Study
Full title
A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
IRAS ID
241363
Contact name
Devraj Srinivasan
Contact email
Sponsor organisation
Soligenix UK Limited
Eudract number
2017-003702-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Approximately 260 patients who are receiving radiation and chemotherapy for mouth cancers will be enrolled into this trial designed to see if a new experimental drug, SGX942, can prevent severe mouth sores (oral mucositis), one of the side effects of the cancer treatment. Subjects will be randomly assigned to receive the experimental drug or a placebo ("sugar pill"). Treatments will be given as a 4-minute intravenous infusion twice a week while the patients receive their standard 5 times a week radiation treatments and for 2 weeks following completion of radiation. The severity of the mouth ulcers will be observed at each drug treatment session and involves a visual inspection of the mouth and throat and several questions about the patient's ability to eat and drink. Patients will have routine blood tests at Screening/Baseline, then at 3, 6, and 9 weeks while receiving study drug, and then at 4 and 6 weeks after completing radiation treatments. Patients will be asked to answer a questionnaire about their health, activities and mood at 3 times during the trial. Patients will have imaging (PET-CT, CT or MRI) to assess their tumor 3 and 12 months after completing their cancer treatment.
REC name
West of Scotland REC 1
REC reference
18/WS/0098
Date of REC Opinion
3 Jul 2018
REC opinion
Further Information Favourable Opinion