Study on Combining Stereotactic Body Radiotherapy with FAK and RAF/MEK Inhibitors for Advanced Pancreatic Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07126158

This clinical trial is exploring whether adding two new drugs, defactinib and avutometinib, to a type of targeted radiation therapy can help improve outcomes for patients with advanced pancreatic cancer.

Patient Parameters

Program Overview

The study aims to find out if using a combination of targeted radiation therapy, known as stereotactic body radiotherapy (SBRT), along with two drugs, defactinib and avutometinib, can help patients with advanced pancreatic cancer live longer without the disease getting worse. This approach will be compared to historical data of patients who received only the radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Have advanced pancreatic cancer that cannot be removed by surgery or is difficult to operate on.
  • Cancer must be confirmed by lab tests and meet specific medical criteria.
  • Have received at least two months of chemotherapy without the cancer getting worse.
  • Be 18 years or older.
  • 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 a life expectancy of more than three months.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.5 K/cumm.
    • Platelet count of at least 100 K/cumm.
    • Hemoglobin level of at least 9.0 g/dL.
    • Normal liver and kidney function as indicated by specific blood tests.
  • Have good heart function with a left ventricular ejection fraction of at least 55%.
  • Agree to use effective contraception during the study and for a specified period after treatment.
  • Be able to understand and sign a consent form, or have a representative do so on their behalf.

Exclusion Criteria

  • Have a history of other cancers unless treatment was completed at least two years ago and there is no evidence of disease.
  • Have fluid buildup in the abdomen or around the lungs that requires drainage.
  • Have previously received certain types of cancer treatments, including FAK or RAF/MEK inhibitors.
  • Have a history of severe allergic reactions to similar drugs used in the study.
  • Have an active autoimmune disease requiring treatment in the past two years.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a history of hepatitis B or active hepatitis C infection.
  • Have a history of lung inflammation requiring steroids.
  • Have had major surgery within 28 days before starting the study.
  • Be pregnant or breastfeeding.
  • Have HIV with low CD4+ T-cell counts or a history of certain infections.
  • Have had a recent COVID-19 infection.
  • Be taking medications that interact with the study drugs.
  • Have difficulty swallowing pills or have certain digestive issues.
  • Have a history of serious muscle breakdown.
  • Have certain eye conditions or heart problems.
  • Have any other medical condition that could increase the risk of side effects.
  • Have an active infection that is not improving with treatment.
  • Have brain metastases requiring treatment with steroids or other interventions.

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