Study on Enfortumab Vedotin for Previously Treated Advanced Pancreatic Cancer (EPIC)
Sponsor: University of Kansas Medical Center
ClinicalTrials ID:NCT05915351
This clinical trial is testing the effectiveness and safety of Enfortumab Vedotin, a drug already approved for bladder cancer, in patients with advanced pancreatic cancer that has returned or spread after previous treatments.
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Program Overview
This study is exploring the use of Enfortumab Vedotin, a drug that targets cancer cells, in patients with advanced pancreatic cancer that has come back or spread after other treatments. The trial aims to see how well the drug works and how safe it is for these patients.
Description
Enfortumab Vedotin is a type of drug that combines an antibody with a cancer-fighting agent to target and kill cancer cells. It is already approved for treating bladder cancer. This study is testing its use in patients with advanced pancreatic cancer that has returned or spread after previous treatments. The trial will evaluate how effective the drug is in shrinking tumors and how safe it is for patients to use. Participants will receive the drug and be monitored for any side effects and changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand the study and agree to participate, or have a representative who can do so.
- Must be 18 years or older.
- Have advanced pancreatic cancer that has returned or spread after at least one previous treatment.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable cancer that can be tracked using standard criteria.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Must provide a previous tumor sample or agree to a new biopsy if needed.
- Have adequate blood cell counts and organ function, including:
- Neutrophil count above 1.5K/UL (or 1K/UL if diagnosed with benign neutropenia).
- Platelet count above 100K/UL.
- Hemoglobin level of at least 9 g/dL.
- Normal kidney and liver function as indicated by specific blood tests.
- Agree to use effective contraception during the study and for a specified period after the last dose of the study medication.
Exclusion Criteria
- Currently participating in another clinical trial.
- Planning to use other cancer treatments during the study.
- Have a psychiatric or social condition that would interfere with the study.
- Allergic to any component of the study drug.
- Have a severe infection within two weeks before starting the study.
- Have ongoing nerve damage or numbness.
- Have untreated or active cancer spread to the brain.
- Require high doses of steroids or other immune-suppressing drugs.
- Have previously received Enfortumab Vedotin or similar drugs.
- Have an active infection requiring treatment at the start of the study.
- Have certain viral infections like hepatitis B or C, or HIV, unless controlled.
- Have active tuberculosis.
- Have had a recent stroke, heart attack, or severe heart condition.
- Have had recent major surgery or radiation therapy.
- Have active eye infections or lung diseases.
- Have had a stem cell or organ transplant.
- Have received a live vaccine recently.
- Have uncontrolled diabetes or other medical conditions that would interfere with the study.
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