Phase 2 Study to Evaluate the Efficacy and Safety of TPST-1495 in Patients With Familial Adenomatous Polyposis (FAP)
National Cancer Institute (NCI)
Summary
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.
Description
PRIMARY OBJECTIVES: I. To assess the activity of TPST-1495 in reducing duodenal polyp burden in patients with FAP. II. To assess the safety of TPST-1495 in patients with FAP; we will evaluate the incidence of grade 2 or 3 adverse events. SECONDARY OBJECTIVE: I. The activity of TPST-1495 in reducing rectum/IPAA (ileal pouch-anal anastomosis) polyp burden in patients with FAP. EXPLORATORY OBJECTIVES: I. Reduction in intestinal polyp burden as a function of immunohistochemical staining at baseline and end of intervention (6-months) of rectal and duodenal tissue samples for COX-2 expression…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of familial adenomatous polyposis (FAP), defined as at least one of the following: * Genetic diagnosis with confirmed APC mutation (clinical CLIA \[clinical laboratory improvement amendments\] certified lab or research testing) * Obligate carrier * Clinical diagnosis of classic FAP with ≥ 100 colorectal adenomas status post colectomy or a sub-total colectomy and a family history of FAP * Clinical diagnosis of FAP, based on personal and family history. Note: This criterion requires documented review and agreement from either the study chair or the MW co…
Interventions
- ProcedureBiopsy Procedure
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- DrugEP2/EP4 Antagonist TPST-1495
Given PO
- ProcedureEsophagogastroduodenoscopy
Undergo EGD
- ProcedureGastrointestinal Endoscopy
Undergo GI endoscopy
- OtherQuestionnaire Administration
Ancillary studies
Locations (4)
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Mayo Clinic in RochesterRochester, Minnesota
- Huntsman Cancer Institute/University of UtahSalt Lake City, Utah
- University of Wisconsin Carbone Cancer Center - University HospitalMadison, Wisconsin