GC4419 when Administered to Reduce Severe Oral Mucositis post Chemo
Research type
Research Study
Full title
An Open Label Multi-Center Study of the Effects of Superoxide Dismutase Mimetic GC4419 when Administered to Reduce the Incidence and Severity of Severe Oral Mucositis (SOM) Associated with Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer
IRAS ID
272165
Contact name
Rafael Moleron Mancebo
Contact email
Sponsor organisation
Galera Theraputics, Inc
Eudract number
2019-002745-38
ISRCTN Number
ISRCTN12345678
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
111,539, IND Number
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
The purpose of this phase 2 study is to learn how safe and tolerable the research drug, GC4419, is to use after chemotherapy and radiotherapy, to reduce the incidence and severity of severe oral mucositis (SOM) associated with the treatment of patients suffering from head and neck cancer. Patients may experience severe oral mucositis (SOM) as a result of the radiation therapy they have been receiving for the treatment of the cancer.
Oral mucositis means the inflammation and ulceration in the mouth and is a common side effect of chemotherapy and radiotherapy treatment for cancer.
GC4419 is the research drug in this study because it has not been approved yet by The Medicines and Healthcare products Regulatory Agency (MHRA). The study will also measure the frequency of SOM and the tumour outcomes.There are 4 stages to this study screening, treatment period, post-radiation Oral Mucositis OM Follow Up, long-term Follow Up. Patients will receive 90mg of the research drug GC4419 per day from Monday to Friday during 7 weeks.
Approximately 70 participants will take part in the study at 35 research sites in Europe.REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0335
Date of REC Opinion
16 Jan 2020
REC opinion
Further Information Favourable Opinion