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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Pyrvinium

Criteria

Inclusion Criteria:

• Patients with pancreatic ductal adenocarcinoma (PDAC) 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 irritable bowel syndrome [IBS])

• Kidney function impairment (serum creatine > 1.5 x ULN or creatine clearanceml/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