NCT05055323

A Study to Determine if the Drug, Pyrvinium Pamoate, is Safe and Tolerable in Patients With Pancreatic Cancer

A Phase I Dose Escalation Study Using Pyrvinium Pamoate Targeting HuR in Pancreatic Ductal Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of pyrvinium pamoate for the treatment of pancreatic ductal adenocarcinoma that cannot be removed by surgery (resectable). Pyrvinium pamoate may slow down tumor growth and help patients live longer.

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety and tolerability of pyrvinium pamoate (PP), dosed orally, in patients with pancreatic ductal adenocarcinoma (PDAC) that are surgical candidates. SECONDARY OBJECTIVE: I. Assessment of PP's pharmacokinetic and pharmacodynamic (PK/PD) profile and bioavailability in humans. OUTLINE: This is a dose-escalation study. Patients receive pyrvinium pamoate orally (PO) once daily (QD) for 3 days in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. After completion of study treatment, patients are followed up for 30 days and then every week for up to 4 weeks.

Conditions

• Resectable Pancreatic Ductal Adenocarcinoma
• Stage 0 Pancreatic Cancer AJCC v8
• Stage I Pancreatic Cancer AJCC v8
• Stage IA Pancreatic Cancer AJCC v8
• Stage IB Pancreatic Cancer AJCC v8
• Stage II Pancreatic Cancer AJCC v8
• Stage IIA Pancreatic Cancer AJCC v8
• Stage IIB Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Pyrvinium Pamoate	Given PO

Timeline

• Start date: 2021-07-29
• Primary completion: 2024-08-01
• Completion: 2026-12-31
• First posted: 2021-09-24
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study