Spots Global Cancer Trial Database for A Study to Determine if the Drug, Pyrvinium Pamoate, is Safe and Tolerable in Patients With Pancreatic Cancer

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Trial Identification

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

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

Study ID: NCT05055323

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

Pyrvinium Pamoate

Study Description

Brief 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.