Use of Pyrvinium to Reverse Stomach Precancerous Conditions

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational University Hospital, Singapore

About this trial

This study is carried out to find out if a drug called pyrvinium is able to convert pre-cancerous tissue in the stomach back to healthy tissue, to lower the chances of stomach cancer. Pyrvinium is a drug that has been used for a long time to treat pinworms in children and its anti-cancer properties are currently under investigation. Tests in animals have shown that pyrvinium made unhealthy tissue healthier and stopped some cells from growing in a bad way. Based on preclinical studies, the investigators hypothesise that the proportion of samples with pre-cancerous tissue in the stomach would decrease by 50% after exposure to pyrvinium at the 6-week timepoint, with anticipated durability of the response at the one-year follow-up.

Eligibility criteria

Qualifiers

The subject is at least 21 years of age.

The subject has histologically proven extensive/marked intestinal metaplasia and/or dysplasia.

The subject is willing and able to provide signed and dated patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.

Disqualifiers

The subject has an active gastric cancer diagnosis.

The subject is pregnant.

The subject has a high-risk of bleeding complications due to anticoagulants or underlying medical condition such as bleeding disorders in whom biopsies are contraindicated.

The subject has impaired renal function.

Trial design

Treatments tested in this trial

  • Placebo
  • Pyrvinium
  • Blood biomarkers analyses
  • Oesophagogastroduodenoscopy (OGD) and biopsy
  • Gastric juice, saliva and stool collection and analyses

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National University Hospital, Singapore

Lead sponsor

National University of Singapore

Collaborator

Vanderbilt University Medical Center

Collaborator