Study on Radiotherapy Combined with TTI-101 for Patients with Borderline Resectable Pancreatic Cancer

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06141031

This clinical trial is testing the safety and effectiveness of a new treatment combining TTI-101 with targeted radiation therapy for patients with pancreatic cancer that is difficult to remove surgically.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if combining a new drug, TTI-101, with a type of targeted radiation therapy called Stereotactic Body Radiation Therapy (SBRT) is safe and effective for treating pancreatic cancer that is challenging to remove with surgery.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of pancreatic cancer that is difficult to remove surgically, as defined by specific medical guidelines.
  • Have received initial chemotherapy as part of standard treatment.
  • Be 18 years or older.
  • Be willing to sign a consent form and follow all study procedures.
  • Be able to swallow tablets.
  • Be in relatively good health, with a performance status score indicating ability to carry out daily activities.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,500/mcL.
    • Platelet count of at least 75,000/mcL.
    • Hemoglobin level of at least 9 g/dL.
    • Serum albumin level of at least 2.8 g/dL.
    • Total bilirubin level of 2 mg/dL or lower.
    • Liver enzymes within specified limits.
    • Kidney function within specified limits.
  • Agree to use effective contraception during the study and for 30 days after the last dose if sexually active.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Previous treatment with a STAT inhibitor for the current cancer.
  • Use of herbal supplements like St. John's wort or ginseng during the study.
  • Not fully recovered from COVID-19 symptoms if previously infected.
  • Ongoing side effects from previous treatments, unless mild.
  • Recent major surgery or not fully recovered from surgery.
  • Severe heart problems or recent heart attack.
  • Fluid buildup around the lungs, heart, or abdomen requiring frequent drainage.
  • Recent stroke or brain issues.
  • Uncontrolled high calcium levels in the blood.
  • Bleeding disorders or significant blood clotting issues.
  • Severe allergic reactions to similar drugs as TTI-101.
  • Active cancer spread to the brain unless stable.
  • Digestive issues affecting medication absorption.
  • Known HIV infection.
  • Chronic hepatitis B unless under control.
  • Recent history of other cancers, except for certain skin or cervical cancers.
  • Severe uncontrolled medical conditions that pose safety risks.
  • Recent treatment for pancreatic cancer outside of initial chemotherapy.
  • Distant cancer spread after chemotherapy.
  • Participation in other clinical trials or use of investigational drugs recently.

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