Study on Ifetroban for Patients with High-Risk Malignant Solid Tumors

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03694249

Provider View

This clinical trial is exploring the effects of ifetroban, a drug that may help prevent cancer from spreading by making blood cells less sticky. The study focuses on patients with solid tumors that have a high chance of returning and spreading after treatment.

Patient Parameters

Program Overview

This study is testing ifetroban, a drug that might help stop cancer from spreading by making blood cells less sticky. Cancer cells can use blood cells to travel to other parts of the body. The trial aims to see if ifetroban can reduce this risk in patients with solid tumors that are likely to come back and spread after treatment. Participants will be randomly assigned to receive either ifetroban or a placebo (a pill with no active drug) once a day for up to a year, as long as their cancer does not progress or they do not experience severe side effects. After finishing the treatment, patients will have follow-up visits for up to a year.

Description

The main goal of this study is to see if ifetroban is safe and can be used in patients with solid tumors that have a high risk of coming back and spreading after treatment. Researchers also want to see how often cancer returns after using ifetroban and to study how the drug works in the body.

Participants will be divided into two groups. One group will take ifetroban by mouth once a day, and the other group will take a placebo, which looks like the drug but has no active ingredients. Both groups will continue their treatment for 28-day cycles over 12 months, unless their cancer worsens or they experience unacceptable side effects. After completing the treatment, patients will have follow-up visits at 30 days and then up to 12 months.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a current diagnosis of a stage I to III solid tumor with a high risk of coming back and spreading (as determined by a doctor).
  • Completed all standard cancer treatments within 120 days before joining the study.
  • Have recovered from any side effects of previous treatments.
  • Have a platelet count of at least 100,000 per microliter of blood.
  • Have a hemoglobin level of at least 9 g/dL.
  • Have normal kidney and liver function as shown by specific blood tests.
  • Women who can have children and men who are not sterile must agree to use two forms of birth control during the study and for five months after the last dose.
  • Must be able to understand and sign a consent form.
  • Can re-enroll if they did not receive the study drug previously.

Exclusion Criteria

  • Have evidence of cancer that has spread to distant parts of the body after standard treatment.
  • Currently using blood-thinning medications or anti-platelet drugs.
  • Have had another active cancer within the last five years, except for certain types with high cure rates.
  • Have serious uncontrolled health conditions that could affect safety.
  • Have had recent chemotherapy, major surgery, radiation, or investigational therapy within specified time frames before starting the study.
  • Have heart problems, such as heart failure, unstable heart rhythms, or high blood pressure that is not controlled.
  • Have ongoing stomach ulcers or a history of bleeding disorders.
  • Are pregnant or breastfeeding.
  • Are prisoners or involuntarily incarcerated.
  • Have a psychiatric condition or other medical issue that could interfere with understanding the study or following its requirements.

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