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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at pre-dose and 2-and 4-hours post-dose at 3 months visit

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

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020