Ifetroban for Preventing Cancer Spread

Overseen By Vanderbilt-Ingram Service for Timely Access

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vanderbilt-Ingram Cancer Center

Must not be taking: Anti-platelet, Anticoagulants

Disqualifiers: Metastatic disease, Active malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 12 months

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. ^{1 2 3 4 5}

Why 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. ^{1 3 5 6 7}

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

Administration of an investigational agent prior to enrollment needs to be completed at least 30 days prior to enrollment

I agree to use two forms of birth control if I can have children or am a man who is not sterile.

Platelet count must be at least 100,000 per mL of blood

Exclusion Criteria

My cancer has spread to distant parts of my body after standard treatment.

I am currently taking medication to prevent blood clots.

I haven't had any cancer except for non-invasive types or highly curable ones in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ifetroban or placebo orally once daily for 12 months

12 months

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up at 30 days, then up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ifetroban Sodium
• Placebo

Trial Overview

The trial is testing Ifetroban Sodium against a placebo to see if it makes platelets less sticky and reduces the chance of cancer spreading. It's for patients whose cancers are likely to recur and spread after initial treatment.

How Is the Trial Designed?

Group I: Group 1 (ifetroban) Experimental Treatment 1 Intervention

ifetroban capsule (250mg) will be taken by mouth daily.

Group II: Group 2 (placebo) Placebo Group 1 Intervention

Placebo capsule (250mg) will be taken by mouth daily.

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Cumberland Pharmaceuticals

Industry Sponsor

Trials

63

Recruited

9,400+

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

Published Research Related to This Trial

New treatments like regorafenib and TAS-102 have been shown to improve progression-free survival and overall survival in patients with heavily pretreated metastatic colorectal cancer, leading to their approval in the U.S. and globally.

The study highlights the importance of evaluating both the benefits and toxicities of these new agents, as they are used after standard chemotherapy and targeted therapies in patients with RAS wild-type tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Agent Therapies After Standard Combination Regimens. Chokshi, S., Hochster, HS.[2020]

Citations

1.

withpower.com

withpower.com/trial/phase-3-neoplasms-11-2018-5ab94

Ifetroban for Preventing Cancer Spread · Info for Participants

The trial is testing Ifetroban Sodium against a placebo to see if it makes platelets less sticky and reduces the chance of cancer spreading.

2.

news.vumc.org

news.vumc.org/2019/07/08/clinical-study-prevent-cancer-metastasis/

Clinical study tests drug that may prevent cancer metastasis

Cook and her colleagues found that ifetroban prevented or delayed metastasis of different cancer types and that it appeared to act on blood ...

3.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-01930

Ifetroban in Treating Patients with Malignant Solid Tumors ...

Drugs, such as ifetroban, may help these platelets become less "sticky," and reduce the chance of cancer cells spreading to other places in the body.

4.

mycancergenome.org

mycancergenome.org/content/drugs/ifetroban/

ifetroban

... ifetroban can reduce the stickiness of the platelets and prevent metastasis. TxA2 causes vascular contraction and platelet activation. Clinical Trials. View ...

5.

aacrjournals.org

aacrjournals.org/mct/article/19/12/2454/274242/Repurposing-of-a-Thromboxane-Receptor-Inhibitor

Repurposing of a Thromboxane Receptor Inhibitor Based on a ...

This landmark clinical trial will test the feasibility of a pharmaco-preventive strategy that may diminish metastatic burden in certain cancer patients. The ...

6.

msn.com

msn.com/en-us/money/savingandinvesting/cumberland-pharmaceuticals-promising-phase-ii-study-on-ifetroban-for-ipf/ar-AA1PiWvG

Cumberland Pharmaceuticals' Promising Phase II Study on ...

The study aims to evaluate the safety and efficacy of oral Ifetroban, a drug designed to prevent and treat lung fibrosis, in patients suffering from IPF.

7.

medchemexpress.com

medchemexpress.com/ifetroban-sodium.html?srsltid=AfmBOoqNlHp3LN_UYD6J5YOXqCARcmB7x9IpKFUR-k4Q56YalRDfddWf

Ifetroban sodium (Synonyms: BMS-180291 sodium)

Ifetroban sodium shows antiplatelet activity, and inhibits tumor cell migration without affecting cell proliferation.