A Phase 1 interventional study of Pyrvinium Pamoate in Resectable Pancreatic Ductal Adenocarcinoma, Stage 0 Pancreatic Cancer AJCC v8 and Stage I Pancreatic Cancer AJCC v8, sponsored by Thomas Jefferson University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Thomas Jefferson University · Phase 1, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 20 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients regardless of age or gender must agree to observe proper contraceptive methods as to avoid becoming pregnant or causing pregnancy for the duration of the study (30 days after last dose of drug)
Exclusion Criteria:
Patients with liver function impairment: Alkaline phosphatase, ALT and AST above three folds the normal limit (see normal ranges); Total Bilirubin level > 3mg/dl; Albumin \< 3g/dl
* Alkaline phosphatase:
Patients with liver function impairment outside of the below ranges
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]):
** Male (M): 1-45 IU/L at 37 degrees Celsius
** Female (F): 1-30
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]):
Patients with liver function impairment outside of the below ranges
* Albumin:
Patients with liver function impairment outside of the below ranges
* Bilirubin, total:
** 0.1-0.9 mg/dL
Patients with liver function impairment outside of the below ranges * Protein, total:
Patients receive pyrvinium pamoate PO QD for 3 days in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery.
Drug: Pyrvinium Pamoate
Given PO
Also known as: 3546-41-6
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
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Thomas Jefferson University