Study comparing the efficacy and safety of clonidine

• Research type

  Research Study

• Full title

  A Phase 2b/3, multicenter, randomized, double-blind, placebocontrolled study comparing the efficacy and safety of clonidine mucoadhesive buccal tablet to placebo to prevent chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer

• IRAS ID

  1004829

• Contact name

  Andrew Mazar

• Contact email

  mazar@monopartx.com

• Sponsor organisation

  Monopar Therapeutics Inc.

• Eudract number

  2021-000999-11

• Research summary

  Oral mucositis (OM) is a painful inflammation and ulceration of the mucous membranes lining of the mouth, the oropharynx, nasopharynx, hypopharynx, larynx, and salivary glands.
  Patients receiving radiotherapy, chemotherapy for head and neck cancer often develop OM, which remains one of the most common side effects of anti-cancer treatments.
  This research study is studying clonidine HCl mucoadhesive buccal tablets (MBT) as a possible treatment for severe oral mucositis caused by chemotherapy drugs and radiation treatment. In this study, the clonidine or placebo will be administered in the form of a MBT. MBT is a special type of tablet designed to stick to the gum, preventing it from being swallowed in order to keep the tablet in the mouth, where it is needed to work.

  Patients will be recruited sequentially into either Stage 1 or Stage 2 of the study. An interim analysis will be conducted when Stage 1 patients (approximately 80 randomised patients) have either completed their CRT or discontinued from the study.
  The Data Monitoring Committee (DMC) will review the Stage 1 efficacy and safety data at the interim analysis. Recruitment into Stage 2 will commence while the interim analyses are being conducted. Phase 2b (Stage 1) will involve approximately 30 sites in the United States and 8 sites in Europe. Phase 3 (Stage 2)will involve approximately 50 sites in the US and Europe.

  To be eligible, patients must have oropharyngeal cancer (OPC) undergoing chemoradiation therapy. Each patient is expected to participate in the study for approximately 27 months.
  
  The study is sponsored by Monopar Therapeutics Inc.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  22/EE/0036

• Date of REC Opinion

  8 Apr 2022

• REC opinion

  Further Information Unfavourable Opinion