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

Launched by THOMAS JEFFERSON UNIVERSITY · Sep 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called pyrvinium pamoate to see if it is safe and tolerable for patients with pancreatic cancer that can be surgically removed. The goal is to find out if this drug can help slow down tumor growth and potentially help patients live longer. If you or a loved one has been diagnosed with pancreatic ductal adenocarcinoma and is considered a good candidate for surgery, you may be eligible to participate in this study.

To join the trial, participants need to be at least 65 years old and must not have received any cancer treatment in the three weeks prior to starting the study. They should also have a life expectancy of more than three months and be able to follow the study procedures. Participants will need to provide consent and agree to use proper contraceptive methods during the study. If you decide to participate, you can expect to be closely monitored for any side effects of the medication and to follow specific guidelines throughout the trial.

Gender

ALL

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