Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557733
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
An Investigational Drug TPST-1495 in Patients With Familial Adenomatous Polyposis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2 Study to Evaluate the Efficacy and Safety of TPST-1495 in Patients With Familial Adenomatous Polyposis FAP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief 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
Detailed 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 examine the number of patients with grade 2 or 3 adverse events
SECONDARY OBJECTIVE
I The activity of TPST-1495 in reducing rectumIPAA 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 level beta-catenin and Ki-67
II Proteomic profile of serum correlated to clinical response to therapy compared between baseline and end of intervention
III Biospecimen acquisition IV TPST-1495 concentrations in plasma at pre-dose 2- and 4-hours post-dose at month 3 visit to assess steady-state pharmacokinetics
OUTLINE
Patients receive TPST-1495 orally PO once daily QD for 6 months in the absence of unacceptable toxicity Patients also undergo esophagogastroduodenoscopy EGD and gastrointestinal GI endoscopy with biopsy at baseline and end of treatment and undergo blood sample collection throughout the study
After completion of study treatment patients are followed up at 1 month
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 examine the number of patients with grade 2 or 3 adverse events
SECONDARY OBJECTIVE
I The activity of TPST-1495 in reducing rectumIPAA 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 level beta-catenin and Ki-67
II Proteomic profile of serum correlated to clinical response to therapy compared between baseline and end of intervention
III Biospecimen acquisition IV TPST-1495 concentrations in plasma at pre-dose 2- and 4-hours post-dose at month 3 visit to assess steady-state pharmacokinetics
OUTLINE
Patients receive TPST-1495 orally PO once daily QD for 6 months in the absence of unacceptable toxicity Patients also undergo esophagogastroduodenoscopy EGD and gastrointestinal GI endoscopy with biopsy at baseline and end of treatment and undergo blood sample collection throughout the study
After completion of study treatment patients are followed up at 1 month
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