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

NCT ID: NCT05055323

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2026-12-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pyrvinium Pamoate

Intervention Type: DRUG

Given PO

Interventions

Pyrvinium Pamoate

Given PO

Intervention Type: DRUG

Other Intervention Names

3546-41-6

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harish Lavu, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37848297 (View on PubMed)

Other Identifiers

JT 14689

Identifier Type: OTHER

Identifier Source: secondary_id

20F.041

Identifier Type: -

Identifier Source: org_study_id