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Active, not recruitingNCT05055323Updated Jul 21, 2026

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Pancreatic Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 \</= 60 ml/1.73m\^2 fr patients with creatine levels > 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

Interventions

  • DrugPyrvinium Pamoate

    Given PO

    Also known as: 3546-41-6

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Profile of pyrvinium pamoate (PP)

    Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).

    Time frame: At Start of Treatment

  2. Profile of pyrvinium pamoate (PP)

    Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).

    Time frame: Completion of treatment

  3. Bioavailability of PP

    Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).

    Time frame: Up to 4 weeks

  4. Fatty tissue accumulation of PP

    Will be assessed using liquid chromatography followed by mass spectrometry (LC/MS).

    Time frame: Up to 4 weeks

07

Study locations

1 site
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

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. PubMed 37848297 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05055323
Lead sponsor
Thomas Jefferson University
Responsible party
Sponsor
First posted
Sep 24, 2021
Start date
Jul 29, 2021
Primary completion
Aug 1, 2024
Completion
Dec 31, 2026 (estimated)
Last update
Jul 21, 2026

Study contacts

Harish Lavu, MD
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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