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Resectable Pancreatic Ductal AdenocarcinomaPhase 1NCT05055323

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

A Phase 1 study testing Pyrvinium Pamoate in people with Resectable Pancreatic Ductal Adenocarcinoma and Stage 0 Pancreatic Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pyrvinium Pamoate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
29 Jul 2021to 31 Dec 2026
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 35Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

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

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:

  1. 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:

  1. 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.

Being tested
Pyrvinium Pamoate
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pyrvinium PamoateDrug

    Also called 3546-41-6

    Given PO

Study groups in NCT05055323
Study groupRoleWhat they receive
Treatment (pyrvinium pamoate)ExperimentalPatients receive pyrvinium pamoate PO QD for 3 days in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery.
Receives: Drug: Pyrvinium Pamoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 30 days from last dose

Secondary outcomes (4)

  1. Profile of pyrvinium pamoate (PP)

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

    Measured: At Start of Treatment

  2. Profile of pyrvinium pamoate (PP)

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

    Measured: Completion of treatment

  3. Bioavailability of PP

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

    Measured: Up to 4 weeks

  4. Fatty tissue accumulation of PP

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

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2021
  2. Study start29 Jul 2021
  3. Primary completion1 Aug 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05055323
Sponsor's protocol ID
20F.041
Other IDs
JT 14689
Status last verified
Jul 2026
First submitted
6 Jul 2021
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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

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