Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590454
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
REVerse Intestinal Metaplasia in the Stomach REVISE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Therapeutic Intervention to Reverse Gastric Precancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVISE
Brief Summary:
This study is designed to test the use of Pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer Response will be determined by assessing the extent and quality of the gastric intestinal metaplasia before and after treatment
A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples and also to identify new drugs that may help reverse gastric intestinal metaplasia
A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples and also to identify new drugs that may help reverse gastric intestinal metaplasia
Detailed Description:
The proposed study is an early Phase II Clinical Trial designed to generate additional data regarding safety and efficacy for the use of Pyrvinium an FDA-approved drug no longer in active use The study design includes enrollment in an observational cohort for a research-focused screening upper endoscopy to document the extent and type of gastric intestinal metaplasia in patients previously diagnosed with this condition using a standardized mapping protocol as described below This initial screening research endoscopy is needed as current clinical care is variable due to lack of guidelines for mapping and surveillance The investigators anticipate enrolling 60 participants in the observational cohort for intensive gastric mapping and then of these 60 participants 32 eligible participants after determining eligibility based on presence of high-risk features of the gastric intestinal metaplasia with confirmed extensive gastric intestinal metaplasia will be included in the randomized control trial to receive either Pyrvinium n16 or placebo n16
Treatment is planned as followed
2 weeks of Pyrvinium vs placebo within 3 months of initial research endoscopy
Following the initial endoscopy participants will receive placebo or Pyrvinium 2 mgkgday by mouth once each day for a total of 14 days The drug or placebo will be verified and dispensed from the investigational drug pharmacy using an IND with attention to safety and blinding to research participants and clinical research staff The drug and placebo will be administered as liquid suspensions Medication diary logs will be used and participants will be asked to return bottles that contained the medication
All participants will be advised to use sunblock and wear protective clothing due to potential for sun-sensitivity
Treatment is planned as followed
2 weeks of Pyrvinium vs placebo within 3 months of initial research endoscopy
Following the initial endoscopy participants will receive placebo or Pyrvinium 2 mgkgday by mouth once each day for a total of 14 days The drug or placebo will be verified and dispensed from the investigational drug pharmacy using an IND with attention to safety and blinding to research participants and clinical research staff The drug and placebo will be administered as liquid suspensions Medication diary logs will be used and participants will be asked to return bottles that contained the medication
All participants will be advised to use sunblock and wear protective clothing due to potential for sun-sensitivity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None