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

Last updated: August 1, 2024
Sponsor: Thomas Jefferson University
Overall Status: Active - Recruiting

Phase

1

Condition

Adenocarcinoma

Digestive System Neoplasms

Treatment

Pyrvinium Pamoate

Clinical Study ID

NCT05055323
20F.041
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) suspectedpreoperatively who are deemed to be surgical candidates by the Thomas JeffersonUniversity surgery department. Patients will be assessed by the pancreatic surgeonsin 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 neoadjuvanttreatment 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 thestudy

  • Patients must have an estimated life expectancy of > 3 months, and EasternCooperative Oncology Group (ECOG) performance status of 0-1

  • All patients regardless of age or gender must agree to observe proper contraceptivemethods as to avoid becoming pregnant or causing pregnancy for the duration of thestudy (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 willhave to take a urine human chorionic gonadotropin (HCG) (pregnancy) test priorto enrolling on the study

Exclusion

Exclusion Criteria:

  • Patients with ongoing anticancer therapies, or those who will have received ananticancer 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 </= 60ml/1.73m^2 fr patients with creatine levels > 1.5 x ULN).

  • Patients with liver function impairment: Alkaline phosphatase, ALT and AST abovethree 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

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Pyrvinium Pamoate
Phase: 1
Study Start date:
July 29, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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