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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given PO
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Incidence of dose limited toxicity (DLT)
Considered any grade 3 or higher adverse event due to the drug itself or delay of surgery. Research coordinator will call patient every day to monitor for DLTs.
Time frame: Up to 30 days from last dose
Profile of pyrvinium pamoate (PP)
Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).
Time frame: At Start of Treatment
Profile of pyrvinium pamoate (PP)
Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).
Time frame: Completion of treatment
Bioavailability of PP
Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).
Time frame: Up to 4 weeks
Fatty tissue accumulation of PP
Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).
Time frame: Up to 4 weeks
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