Clinical trial · Interventional
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
NCT05055323CI-TRIAL-00118786active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage 0 Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrvinium Pamoate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (pyrvinium pamoate)
- description
- Patients receive pyrvinium pamoate PO QD for 3 days in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery.
- interventionNames
- Drug: Pyrvinium Pamoate
Primary outcomes (1)
- measure
- Incidence of dose limited toxicity (DLT)
- timeFrame
- Up to 30 days from last dose
- description
- Considered any grade 3 or higher adverse event due to the drug itself or delay of surgery. Research coordinator will call patient every day to monitor for DLTs.
Secondary outcomes (4)
- measure
- Profile of pyrvinium pamoate (PP)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPonzini FM, Schultz CW, Leiby BE, Cannaday S, Yeo T, Posey J, Bowne WB, Yeo C, Brody JR, Lavu H, Nevler A. Repurposing the FDA-approved anthelmintic pyrvinium pamoate for pancreatic cancer treatment: study protocol for a phase I clinical trial in early-stage pancreatic ductal adenocarcinoma. BMJ Open. 2023 Oct 17;13(10):e073839. doi: 10.1136/bmjopen-2023-073839. PMID 37848297