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

NCT05055323 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 20F.041JT 14689
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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.

  Up to 30 days from last dose

Secondary Outcomes (4)

• Profile of pyrvinium pamoate (PP)

  At Start of Treatment

• Profile of pyrvinium pamoate (PP)

  Completion of treatment

• Bioavailability of PP

  Up to 4 weeks

• Fatty tissue accumulation of PP

  Up to 4 weeks

Study Arms (1)

Treatment (pyrvinium pamoate)

EXPERIMENTAL

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

Pyrvinium Pamoate DRUG

Given PO

Also known as: 3546-41-6

Treatment (pyrvinium pamoate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• years (yr): 83-280 IU/L at 37 degrees Celsius
• yr: 91-400
• yr: 37-240
• yr: 29-92
• yr: 25-120
• yr: 29-160
• yr: 29-120

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 37848297 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

pyrvinium

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Harish Lavu, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: September 24, 2021
• Study Start: July 29, 2021
• Primary Completion: August 1, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)