TPST-1495 for Adenomatous Polyposis

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: NSAIDs, CYP2D6 inhibitors

Disqualifiers: HIV, Hepatitis B/C, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

38 Participants Needed

Trial Summary

What is the purpose of this trial?

This open-label phase II trial tests how well TPST-1495 works in reducing the number of polyps in the small bowel and colon in patients with familial adenomatous polyposis (FAP). FAP is an inherited condition in which numerous polyps (growths that protrude from mucous membranes) form on the inside walls of the colon and rectum. It increases the risk for colon cancer. TPST-1495 binds to specific prostaglandin receptors. TPST-1495 is a dual antagonist of the prostaglandin E2 (PGE2) receptor subtypes EP2 and EP4, while sparing the immune-stimulating EP1 and EP3 receptors. TPST-1495 may help reduce the number of polyps in the small bowel and colon in patients with FAP.

Will I have to stop taking my current medications?

You will need to stop taking non-steroidal anti-inflammatory drugs (NSAIDs) 5 days before starting the study treatment and limit their use during the study. The protocol does not specify other medication restrictions, but certain antiviral medications and drugs affecting liver enzymes may be excluded.

Research Team

Niloy J Samadder

Principal Investigator

University of Wisconsin Carbone Cancer Center - University Hospital

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with FAP due to an APC mutation or clinical criteria.

Ability to understand and sign a written informed consent document

H. pylori negative confirmed with gastric biopsy at screening EGD

Exclusion Criteria

Use of any other investigational agents ≤ 12 weeks prior to pre-registration

I have had cancer within the last 3 years, with some exceptions.

I have a confirmed severe precancerous condition or cancer, have had bleeding in my digestive tract, and need blood thinners.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TPST-1495 orally once daily for 6 months. They also undergo esophagogastroduodenoscopy (EGD) and gastrointestinal (GI) endoscopy with biopsy at baseline and end of treatment, and blood sample collection throughout the study.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

1 month

Treatment Details

Interventions

• TPST-1495

Trial Overview 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.

Participant Groups

Group I: Prevention (TPST-1495) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+