What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine and nabpaclitaxel, are known to have several side effects. These include fatigue, neuropathy, neutropenia, nausea, and diarrhea. Specifically, gemcitabine can cause neutropenia, which is a significant reduction in white blood cells, leading to an increased risk of infection. Nabpaclitaxel, when combined with gemcitabine, can also cause neuropathy, which is nerve damage that leads to pain, tingling, or numbness, and severe fatigue. These side effects are important considerations for patients undergoing treatment for pancreatic cancer.

What prior FDA approvals exist?

Several FDA-approved treatments for pancreatic cancer focus on inhibiting tumor growth. Gemcitabine, often used in combination with nab-paclitaxel, has shown significant efficacy in improving survival rates and response rates in patients with metastatic pancreatic cancer. Another combination, FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin), has also demonstrated a survival benefit. These treatments aim to slow down tumor progression and improve patient outcomes, similar to the investigational drug pyrvinium pamoate.

What other types of research exist?

Promising novel alternatives to Pyrvinium Pamoate for pancreatic cancer patients include: 1) Olaparib, a PARP inhibitor, particularly for patients with germline BRCA mutations. 2) Niraparib combined with nivolumab or ipilimumab, which has shown promise in phase 1b/2 trials for platinum-sensitive advanced pancreatic cancer. 3) Nanoparticle albumin-bound paclitaxel in combination with gemcitabine, which has demonstrated efficacy and safety in phase I/II trials for patients with an ECOG performance status of 2.

← Back to Search

Anthelmintic

Pyrvinium Pamoate for Pancreatic Cancer

Phase 1

Recruiting

Led By Harish Lavu, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have an estimated life expectancy of > 3 months, and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Be older than 18 years old

Must not have

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 chronic bowel conditions (such as inflammatory bowel disease (IBD))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pyrvinium pamoate, a medication that may slow down the growth of pancreatic cancer. It targets patients whose cancer cannot be removed by surgery. The goal is to see if this treatment can help these patients live longer.

Who is the study for?

This trial is for patients with pancreatic ductal adenocarcinoma that can't be surgically removed. Participants must not be on recent anticancer therapy, agree to use contraception, and have a life expectancy over 3 months with good performance status. Excluded are pregnant or breastfeeding individuals, those with chronic bowel conditions, kidney or liver function impairment.

What is being tested?

The study tests the safety and optimal dosage of Pyrvinium Pamoate (PP) in treating non-resectable pancreatic cancer. It aims to determine if PP can slow tumor growth and extend patient survival.

What are the potential side effects?

While specific side effects for Pyrvinium Pamoate in this context aren't detailed, common reactions may include digestive issues, allergic reactions to its components, and potential impacts on liver or kidney functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am expected to live more than 3 months and can carry out all my self-care activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is impaired.

Select...

I have a long-term bowel condition like IBD.

Select...

I cannot have surgery on my pancreas due to my current health condition.

Select...

My liver isn't working well, with high enzyme levels and bilirubin, and low albumin.

Select...

My liver function tests are within normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days from last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days from last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days from last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limited toxicity (DLT)

Secondary study objectives

Bioavailability of PP

Fatty tissue accumulation of PP

Profile of pyrvinium pamoate (PP)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pyrvinium pamoate)Experimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer, such as gemcitabine and fluoropyrimidines, work by interfering with DNA synthesis and cell division, thereby inhibiting tumor growth. Gemcitabine incorporates into DNA strands, causing premature termination of DNA replication, while fluoropyrimidines like capecitabine are converted into active metabolites that disrupt DNA and RNA synthesis. Pyrvinium pamoate, an investigational drug, may slow tumor growth by targeting specific cellular pathways involved in cancer cell proliferation. Understanding these mechanisms is crucial for pancreatic cancer patients as it helps in selecting the most effective treatment strategy, potentially improving survival rates and quality of life.

Current and future strategies for combined-modality therapy in pancreatic cancer.