A Study To Determine If The Drug, Pyrvinium Pamoate, Is Safe And Tolerable In Patients With Pancreatic Cancer

Study Overview

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

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.

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

DRUG: Pyrvinium Pamoate

20F.041
JT 14689 (OTHER Identifier) (OTHER: JeffTrial Number)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-07-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-10
First Submitted that Met QC Criteria 2021-09-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-15
First Posted (ACTUAL) 2021-09-24	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (pyrvinium pamoate) 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (pyrvinium pamoate)

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

Primary Outcome Measures	Measure Description	Time Frame
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.	Up to 30 days from last dose

Secondary Outcome Measures	Measure Description	Time Frame
Profile of pyrvinium pamoate (PP)	Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).	At Start of Treatment
Profile of pyrvinium pamoate (PP)	Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).	Completion of treatment
Bioavailability of PP	Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).	Up to 4 weeks
Fatty tissue accumulation of PP	Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).	Up to 4 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) suspected preoperatively who are deemed to be surgical candidates by the Thomas Jefferson University surgery department. Patients will be assessed by the pancreatic surgeons in the pancreatic surgery clinic, and if they are found to have resectable disease, they can be considered for this study
Patients must not be on neoadjuvant therapy, or have received their last neoadjuvant treatment greater than or equal to within three weeks of starting PP therapy
Provide signed and dated informed consent form
Willing to comply with all study procedures and be available for the duration of the study
Patients must have an estimated life expectancy of > 3 months, and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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)

Males will practice safe sex methods (i.e. condoms)
Women of child bearing potential will practice safe sex methods (i.e. condoms, birth control), if a female on the study is of child-bearing age, they will have to take a urine human chorionic gonadotropin (HCG) (pregnancy) test prior to enrolling on the study

Patients with ongoing anticancer therapies, or those who will have received an anticancer therapeutic <3 weeks prior to the first dose of PP
Any condition that precludes pancreatic surgical resection at the time of the study
Pregnancy or currently breastfeeding
Known allergic reactions to components of the study product(s): pyrvinium pamoate/ pyrvinium embonate (Molevac)
Patients with chronic bowel conditions (such as inflammatory bowel disease (IBD))
Kidney function impairment (serum creatine > 1.5 x ULN or creatine clearance 1.5 x ULN).
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:
0-9 years (yr): 83-280 IU/L at 37 degrees Celsius
10-14 yr: 91-400
15-17 yr: 37-240
18-49 yr: 29-92
50-74 yr: 25-120
75-97 yr: 29-160
98-99 yr: 29-120
> 99 yr: 29-160
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]):

M: 7-42 IU/L at 37 degrees Celsius
F: 7-35
Patients with liver function impairment outside of the below ranges

Albumin:
0-1 yr: 2.6-4.4
1-15 yr: 3.0-4.7
16-99 yr: 3.2-4.9
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:

0-1 yr: 4.6-7.2 g/dL
1-15 yr: 5.7-8.2
16-99 yr: 6.0-8.5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Harish Lavu, MD, Thomas Jefferson University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ponzini FM, Schultz CW, Leiby BE, Cannaday S, Yeo T, Posey J, Bowne WB, Yeo C, Brody JR, Lavu H, Nevler A. Repurposing the FDA-approved anthelmintic pyrvinium pamoate for pancreatic cancer treatment: study protocol for a phase I clinical trial in early-stage pancreatic ductal adenocarcinoma. BMJ Open. 2023 Oct 17;13(10):e073839. doi: 10.1136/bmjopen-2023-073839.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record