Ifetroban for Preventing Cancer Spread
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores ifetroban, a drug that might prevent cancer from spreading in individuals with solid tumors likely to recur and metastasize after treatment. Ifetroban aims to reduce the "stickiness" of platelets, potentially decreasing the chance of cancer cells spreading to other body parts. Participants will take either ifetroban daily or a placebo (a harmless pill with no active drug) to assess the drug's effect on cancer spread. The trial is open to those who have had stage I to III solid tumors, completed standard cancer treatments, and are at high risk for recurrence and metastasis. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you stop taking any anti-platelet drugs (like aspirin or NSAIDs) and anticoagulants (like warfarin) before participating. If you're on these medications, you would need to discontinue them to join the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ifetroban sodium has been tested for safety in other conditions, such as lung fibrosis. In these studies, most patients tolerated the drug well, indicating it usually doesn't cause serious side effects.
This trial is a "Phase 2" study, meaning the treatment has already passed initial safety tests in earlier research. While this doesn't guarantee the absence of side effects, it often suggests the drug is safe enough for more detailed testing.
Ifetroban works by reducing the stickiness of blood cells that aid in clotting, which can help prevent cancer from spreading. So far, studies have shown that ifetroban doesn't affect cell growth, which is a positive sign for its safety.
Overall, existing research supports that ifetroban is generally safe, but more studies are needed to confirm this in people with cancer.12345Why do researchers think this study treatment might be promising?
Unlike the standard cancer treatments that focus on killing or stopping the growth of cancer cells, ifetroban is unique because it targets the prevention of cancer spread. Most cancer therapies, like chemotherapy and radiation, aim to directly attack the cancer cells themselves. However, ifetroban works by inhibiting a specific receptor involved in the metastatic process, potentially stopping cancer from spreading to other parts of the body. Researchers are excited about this approach because it could complement existing treatments, offering a new way to manage cancer progression and improve patient outcomes.
What evidence suggests that ifetroban might be an effective treatment for preventing cancer spread?
Research has shown that ifetroban, which participants in this trial may receive, might help prevent cancer from spreading. Studies have found that this drug can reduce the stickiness of platelets, the blood cells involved in clotting. This is important because cancer cells often use platelets to move and spread to new areas. By making platelets less sticky, ifetroban could slow or stop the spread of cancer. Previous studies found that ifetroban delayed the spread of various cancer types, suggesting it might help prevent cancer from returning and spreading after treatment.13567
Who Is on the Research Team?
Sonya Reid
Principal Investigator
Vanderbilt-Ingram Cancer Center
Are You a Good Fit for This Trial?
Adults over 18 with stage I to III solid tumors at high risk of recurrence after treatment can join. They must have finished all standard cancer treatments within the past 120 days, be in good enough health (ECOG status 0-2), and have recovered from previous therapies. Participants need normal organ function tests, not be on blood thinners or anti-platelet drugs, and agree to use two contraception methods if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ifetroban or placebo orally once daily for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ifetroban Sodium
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
Cumberland Pharmaceuticals
Industry Sponsor
A.J. Kazimi
Cumberland Pharmaceuticals
Chief Executive Officer since 1999
B.S. from the University of Notre Dame, MBA from Vanderbilt University Owen Graduate School of Management
Ines Macias-Perez
Cumberland Pharmaceuticals
Chief Medical Officer
Ph.D. in Cancer Biology from Vanderbilt University