NCT06669390

A Mouthwash Medicine for the Reduction or Prevention of Mouth Ulceration Caused by Radiotherapy for Head and Neck Cancer

A Phase-1b Dose Escalation Study to Assess the Effect of NG11-2 on Radiation Induced Oral Mucositis in Patients With Head & Neck Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: VasoDynamics Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is looking at a new medication called NG11-2 to see if it can reduce a side effect called severe Radiation-induced Oral Mucositis (RIOM) that can happen to people getting radiation treatment for head and neck cancer. Severe RIOM can make patients very sick and make it hard for them to finish their cancer treatment. Right now, there are no approved drugs that can prevent or treat severe RIOM. This study will test different doses of NG11-2 to find the best one, and then more patients will take that dose to see if it works. This study is being done at multiple hospitals in the UK.

Detailed description

The main objective of the trial is to see if the use of NG11-2, when administered as a mouthwash in head and neck cancer patients prior to their radiotherapy, is tolerable and can reduce or prevent the development of severe radiation induced oral mucositis. More specifically, the trial aims to identify an appropriate dose of NG11-2 IMP based on safety and activity/preliminary efficacy for subsequent assessment in follow-up clinical trials. Although the primary objective of the trial is to evaluate the safety \& tolerability of NG11-2 mouthwash, the secondary objective is to obtain preliminary data on the activity/efficacy of NG11-2 mouthwash in the reduction of severe RIOM. This is a Phase-1b unblinded, dose escalation, multi-centre study of NG11-2 for the reduction of severe RIOM in Head and Neck cancer patients undergoing radiotherapy, with or without concurrent chemotherapy. The study design is a "2+4" Dose Escalation design with the following escalation schema (a) If 0 out of 2 enrolled patients have a Dose Limiting Toxicity (DLT) , then escalate to the next Dose Level and enroll 2 more patients (b) if 1 out of 2 patients has a DLT, then add 4 more patients at the same Dose Level (c) if 2 out of 2, or 2 or more out of 6 patients experience a DLT, then stop the dose escalation. The Maximum Tolerated Dose (MTD) is one dose level below the level at which 2/2 or 2+/6 patients experienced a DLT. On completion of the Dose Escalation, the Safety Committee will review the available data and a small cohort of patients will be treated at the dose(s) selected by the Safety Committee.. Dosing will start at the 0.92mg/mL (5mM) Dose Level with patients being treated with NG11-2 prior to Radiotherapy on days 1-5 each week for up to 7 weeks. The proposed patient population for this study includes male and female patients, aged 18 or older with histologically confirmed Head and Neck cancer (preferring oral cavity, oropharyngeal, nasopharyngeal cancer), undergoing primary radical chemoradiotherapy/radiotherapy or adjuvant chemoradiotherapy/radiotherapy with either (a) Extended Oral Cavity, or (b) Buccal Mucosa, or (c) Lips receiving a mean radiation dose of at least 30Gy. Safety assessments will include evaluation of adverse events (AEs) using NCI CTCAE v5), clinical laboratory assessments (biochemistry, haematology), vital sign measurements (blood pressure, heart rate), 12-lead electrocardiogram (ECG) measurements, and physical examination. An inspection of the Oral Mucosa will take place every day prior to NG11-2 treatment, except on those days where the Oral Mucositis Scoring Assessment has already occurred, to inspect the condition of the oral mucosa. The severity of Oral Mucositis (OM) will be scored by trained site staff using WHO, RTOG and NCI-CTCAE v5 scales twice weekly (assessments 72hrs apart) from enrolment to the last study drug treatment, then at weeks 1, 2, 4 and 6 post RT. The WHO scale is the primary scoring scale and the RTOG \& NCI-CTCAE v5 scales are exploratory scoring scales. Additionally, a Patient Reported Outcome Measure - Oral Mucositis (PROM-OM) questionnaire will be performed at each Oral Mucositis Scoring Assessment.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DRUG	NG11-2	NG11-2 dose level will vary from 0.92 mg/mL to 5.5 mg/mL during the dose escalation process. The NG11-2 is given as an oral rinse. Throughout the radiotherapy regimen, no more than 60 minutes prior to the completion of radiotherapy, on each weekday the patient will rinse their mouth with 12.5 ml of NG11-2 for between 90 \& 120 seconds duration, gargling twice for approximately three seconds each if possible during this period then expectorate the solution.

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

4 sites across 1 country: United Kingdom