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Prostaglandin Antagonist

TPST-1495 for Adenomatous Polyposis

Phase 2
Waitlist Available
Led By Niloy J Samadder
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of familial adenomatous polyposis (FAP) with confirmed APC mutation or obligate carrier or clinical diagnosis with specific criteria
Age ≥ 18 with specific exclusion for participants < 18 years
Must not have
History of gastric or intestinal ulceration due to NSAID therapy
History of upper GI surgery that limits evaluation of duodenum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-dose and 2-and 4-hours post-dose at 3 months visit
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a drug called TPST-1495 to see if it can reduce the number of polyps in the small bowel and colon of patients with familial adenomatous polyposis (

Who is the study for?
This trial is for patients with familial adenomatous polyposis (FAP), a condition causing many polyps in the colon and increasing colon cancer risk. Details on who can join or reasons for exclusion are not provided.
What is being tested?
The trial tests TPST-1495, which targets specific receptors to potentially reduce polyp numbers in the small bowel and colon of FAP patients. It involves endoscopies, tissue collection, biopsies, and questionnaires.
What are the potential side effects?
Specific side effects of TPST-1495 aren't listed here but may include typical drug reactions such as gastrointestinal discomfort due to its action on prostaglandin receptors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with FAP due to an APC mutation or clinical criteria.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I am on long-term antiviral treatment for herpes simplex virus.
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I am willing to stop taking NSAIDs before starting the study treatment.
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My condition is Spigelman stage 2 or 3 for duodenal polyps.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had stomach or intestinal ulcers caused by pain relievers.
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I have had upper GI surgery that affects duodenum checks.
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I have a confirmed severe precancerous condition or cancer, have had bleeding in my digestive tract, and need blood thinners.
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I do not have any ongoing health issues or recent surgeries that would stop me from following the study requirements.
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I am not taking strong or moderate inhibitors of CYP2D6 and CYP3A4.
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I have an active H. pylori infection that hasn't been cured by antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-dose and 2-and 4-hours post-dose at 3 months visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-dose and 2-and 4-hours post-dose at 3 months visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Percent change in duodenal polyp burden
Secondary study objectives
Percent change in rectal/pouch polyp burden
Other study objectives
Percent change in immunohistochemical staining levels
Proteomic profile
TPST-1495 plasma concentrations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (TPST-1495)Experimental Treatment6 Interventions
Patients receive TPST-1495 PO QD for 6 months in the absence of unacceptable toxicity. Patients also undergo EGD and GI endoscopy with biopsy at baseline and end of treatment and undergo blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Biopsy
2014
Completed Phase 4
~1090
Esophagogastroduodenoscopy
2017
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,799 Total Patients Enrolled
Niloy J SamadderPrincipal InvestigatorUniversity of Wisconsin Carbone Cancer Center - University Hospital
6 Previous Clinical Trials
3,065 Total Patients Enrolled
~25 spots leftby Dec 2026