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

30 Participants Needed

Trial Summary

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.

What makes the drug Ifetroban Sodium unique for preventing cancer spread?

Ifetroban Sodium is unique because it targets a different mechanism compared to standard treatments for colorectal cancer, which often focus on inhibiting angiogenesis (the formation of new blood vessels that tumors need to grow). While other treatments like bevacizumab and regorafenib target vascular endothelial growth factor (VEGF) pathways, Ifetroban Sodium may offer a novel approach by potentially affecting other pathways involved in cancer spread. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial studies ifetroban, a drug that makes blood cells less sticky, in patients with high-risk malignant tumors. The goal is to see if it can safely help prevent cancer from spreading after initial treatments.

Research Team

Sonya Reid

Principal Investigator

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

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 have recovered from my last cancer treatment's side effects.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Targeting vascular endothelial growth factor in colorectal cancer. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Single-Agent Therapies After Standard Combination Regimens. [2020]

3. France pubmed.ncbi.nlm.nih.gov

[Impact of mutational status of KRAS in the care of patients with colorectal cancer metastasis]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

New active drugs for the treatment of advanced colorectal cancer. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

[New molecular-targeted agents for colorectal cancer - regorafenib and aflibercept]. [2013]