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Use of Pyrvinium to Reverse Stomach Precancerous Conditions

ConditionSTOMACH NEOPLASM
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 30% after exposure to pyrvinium at the 6-week timepoint, with anticipated durability of the response at the one-year follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject is at least 21 years of age.

The subject has histologically proven extensive/marked intestinal metaplasia and/or dysplasia. Extensive/ marked IM is defined by: (a) Presence of multifocal IM (IM present in antrum and body), and (b) At least one biopsy with at least moderate IM severity.

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 has a personal history of gastric cancer diagnosis.

The subject has a previous total or partial gastrectomy.

The subject is pregnant (positive urine pregnancy test).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    Participants will receive placebo by mouth once each day for a total of 14 days.

  • Pyrvinium

    Drug

    Participants will receive pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days.

  • Blood biomarkers analyses

    Procedure/Surgery

    Up to 20ml of blood will be drawn from each participant at each study visit, with a total of 4 study visits for molecular analyses.

  • Oesophagogastroduodenoscopy (OGD) and biopsy

    Procedure/Surgery

    Study participant will undergo OGD with collection of gastric mucosal biopsies at the baseline visit to ascertain IM status and for molecular analyses. Study participant will undergo follow-up gastroscopy with collection of gastric mucosal biopsies at day 7 of treatment, 6 weeks post-treatment and 1 year post-treatment to assess if endpoint is reached and for molecular analyses. Gastric juice samples will be collected during each OGD.

  • Gastric juice, saliva and stool collection and analyses

    Other intervention

    Gastric juice will be taken, and gastric pH will be measured at each research endoscopy. Saliva and stool will also be obtained from participants at research endoscopy for microbiome studies at the following timepoints: baseline, 6 weeks post-treatment, and 1 year post-treatment.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PyrviniumExperimental treatment 4 interventions
Group B: PlaceboPlacebo comparator 4 interventions

Trial outcomes

Primary outcomes

1

Histological Regression of GIM: Average percentage change of GIM in the antrum and corpus, as measured by histological evaluation of gastric biopsies at baseline and the study endpoint

Time frame
Baseline, 6 weeks post-treatment

Secondary outcomes

1

Surface Area of GIM Involvement: Measured in real-time using AI-guided imaging technology during endoscopy

Time frame
During endoscopy at baseline, Day 7 of treatment, 6 weeks post-treatment and 1 year post-treatment
2

Safety: Number of participants with treatment-related adverse events

Time frame
From Day 1 to Day 14 of treatment
3

Efficacy in Patient-Derived Gastroids: Changes in phosphorylation levels of proteins in pre-cancerous gastroids derived from participants with GIM or dysplasia

A maximum of 18 research biopsies will be taken at the baseline endoscopy, of which 4 biopsies of areas of known gastric IM will be used to generate gastric organoids.

Time frame
Baseline
4

Efficacy in Patient-Derived Gastroids: Evaluation of growth and proliferation after pyrvinium treatment via imaging, staining and histological techniques

A maximum of 18 research biopsies will be taken at the baseline endoscopy, of which 4 biopsies of areas of known gastric IM will be used to generate gastric organoids.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University Hospital, Singapore

Lead sponsor

National University of Singapore

Collaborator

Vanderbilt University Medical Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: