ACTIVE_NOT_RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Dose Escalation Study Using Pyrvinium Pamoate Targeting HuR in Pancreatic Ductal Adenocarcinoma

Quick Facts

Study Start:2021-07-29

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05055323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 * 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 * 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 * 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 * 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

Inclusion Criteria

Exclusion 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

* 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
* 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
* 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
* 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
* 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

Contacts and Locations

Principal Investigator

Harish Lavu, MD

PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Study Locations (Sites)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Harish Lavu, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-29

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-07-29

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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