Study on Stereotactic Body Radiotherapy and Focal Adhesion Kinase Inhibitor for Advanced Pancreatic Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04331041

Provider View

This clinical trial is testing a new treatment approach for advanced pancreatic cancer, combining standard chemotherapy with targeted radiotherapy and a new drug called defactinib. The study aims to see if this combination can improve outcomes for patients.

Patient Parameters

Program Overview

The study is exploring whether adding a new drug, defactinib, to standard chemotherapy and targeted radiotherapy can help control advanced pancreatic cancer. Patients will be randomly assigned to receive either the new combination treatment or the standard treatment. Researchers will evaluate the effectiveness and safety of the new approach by looking at how long patients live without the cancer getting worse, how well the cancer is controlled locally and in other parts of the body, and any side effects experienced.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced pancreatic cancer that cannot be removed by surgery.
  • Cancer has not spread beyond nearby lymph nodes.
  • Completed at least 3 months of chemotherapy without the cancer getting worse.
  • Aged 18 or older.
  • In good general health, able to carry out daily activities with minimal restrictions.
  • Expected to live for more than 3 months.
  • Normal blood and organ function based on recent tests.
  • Willing to use effective birth control during the study and for a period after.
  • Able to understand and sign a consent form agreeing to participate.

Exclusion Criteria

  • History of another cancer, unless treatment was completed over 2 years ago and there is no sign of it returning.
  • Fluid buildup in the abdomen or around the lungs that needs regular draining.
  • Previous treatment with certain immune or cancer drugs.
  • Allergic reactions to similar drugs used in the study.
  • Currently taking part in another clinical trial or using investigational drugs.
  • Immune system disorders or taking long-term steroids or other immune-suppressing drugs.
  • Unable to stop using the blood thinner warfarin.
  • Serious ongoing health issues, such as infections or uncontrolled high blood pressure.
  • Active autoimmune disease needing treatment in the past 2 years.
  • Recent live vaccinations.
  • History of hepatitis B or active hepatitis C.
  • Lung inflammation needing steroids or current lung issues.
  • Recent major surgery.
  • Pregnant or breastfeeding women.
  • HIV-positive patients with low immune cell counts or recent serious infections.
  • Recent COVID-19 infection.
  • Taking certain medications affecting drug absorption.
  • Difficulty swallowing pills or digestive issues affecting medication absorption.
  • Allergic to ingredients in the study drug.

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