NG11-2-P1b

• Research type

  Research Study

• Full title

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

• IRAS ID

  1004528

• Contact name

  Gary Bower

• Contact email

  gary.bower@vasodynamics.co.uk

• Sponsor organisation

  VasoDynamics Ltd

• Eudract number

  2022-002409-99

• ISRCTN Number

  ISRCTN87831050

• Research summary

  The purpose of the study is to investigate the effect of a new formulation of adrenaline (named NG11-2) in the reduction of severe Radiation-induced Oral Mucositis (RIOM). Severe RIOM is a debilitating side-effect of radiotherapy among patients receiving high dose radiation therapy on the head and neck area for head and neck cancer treatment. Severe RIOM can lead to increased hospital care and is often a dose-limiting factor and cause of radiotherapy interruption and, as a result, leads to a sub-optimal anti-cancer efficacy. There are no approved drugs currently available for prevention & treatment of severe RIOM and care for these patients is primarily supportive.
  The study is a Phase-1b dose escalation , multi-centre study of NG11-2 in the reduction of severe RIOM in Head and Neck cancer patients undergoing radiotherapy, with or without concurrent chemotherapy. Patients will be enrolled at escalating dose levels and once a suitable dose level has been identified, a further cohort of patients will be enrolled at the Recommended Phase-2 Dose (RP2D).

  Daily treatment with NG11-2 will occur prior to radiotherapy for 5 days/week for up to 7 weeks. Throughout the radiotherapy regimen, no more than 60 minutes prior to the completion of radiotherapy, on each weekday the patient will be instructed to
  a) rinse their mouth twice with room temperature water in the 5 minutes prior to NG11-2 treatment then
  b) rinse their mouth with 12.5ml of NG11-2 for between 90 & 120 seconds duration, gargling twice for approximately three seconds each if possible during this period then
  c) expectorate the solution

  Treatment will continue for up to 7 weeks with a 6-week follow-up period.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  22/WM/0262

• Date of REC Opinion

  23 Jan 2023

• REC opinion

  Further Information Favourable Opinion