NCT05055323Active, not recruitingPhase 1
A Study to Determine if the Drug, Pyrvinium Pamoate, is Safe and Tolerable in Patients With Pancreatic Cancer
A Phase I Dose Escalation Study Using Pyrvinium Pamoate Targeting HuR in Pancreatic Ductal Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 6 Jul 2021
- Start date
- 29 Jul 2021
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Pancreatic cancer
- NCT number
- NCT05055323
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 29 Jul 2021 to the primary completion date, 1 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with ongoing anticancer therapies, or those who will have received an anticancer therapeutic \<3 weeks prior to the first dose of PP
Other illness
- Any condition that precludes pancreatic surgical resection at the time of the study
- 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))
Lab values
- 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
Other
- Pregnancy or currently breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.