Evaluating the safety of Pyrvinium Pamoate in patients with pancreatic cancer
A Phase I Dose Escalation Study Using Pyrvinium Pamoate Targeting HuR in Pancreatic Ductal Adenocarcinoma
This study is testing if an oral medication called Pyrvinium Pamoate is safe for people with pancreatic cancer before they have surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05055323 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and tolerability of Pyrvinium Pamoate, an oral medication, in patients with resectable pancreatic ductal adenocarcinoma. The study involves a dose-escalation approach where patients receive the drug for three days before undergoing standard surgical treatment. Additionally, the trial aims to assess the pharmacokinetic and pharmacodynamic profile of the drug in humans. Patients will be monitored for side effects and overall health for a period following treatment.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with resectable pancreatic ductal adenocarcinoma who are surgical candidates and have not received recent neoadjuvant therapy.
Not a fit: Patients with unresectable pancreatic cancer or those currently undergoing neoadjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with pancreatic cancer.
How similar studies have performed: While this approach is novel for this specific condition, similar studies evaluating the safety of new treatments in pancreatic cancer have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Harish Lavu, MD — Thomas Jefferson University
- Study coordinator: Harish Lavu, MD
- Email: Harish.Lavu@jefferson.edu
- Phone: 215-955-9402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.