What side effects are associated with this type of intervention?

Common treatments for cancer that affect platelet function, such as Ifetroban, often aim to reduce the risk of metastasis by preventing cancer cells from using platelets to spread. Side effects of these treatments can include bleeding complications due to reduced platelet aggregation. Other cancer treatments, such as chemotherapy and targeted therapies, frequently cause hematological adverse events like neutropenia, anemia, and thrombocytopenia. Specific drugs like niraparib and rucaparib are associated with high rates of anemia and neutropenia. Additionally, treatments like ibrutinib combined with obinutuzumab can lead to serious adverse events, including neutropenia and thrombocytopenia.

What prior FDA approvals exist?

Several FDA-approved drugs for cancer treatment have properties that reduce platelet aggregation, similar to Ifetroban. For instance, Vorapaxar, an antagonist of protease-activated receptor-1 (PAR-1) on platelets, has been studied for its potential to reduce thrombotic events in cancer patients. Additionally, antiplatelet agents like aspirin and anticoagulants have been explored for their benefits in managing cancer-related thrombotic complications. These treatments aim to mitigate the risk of cancer cells spreading by reducing platelet 'stickiness' and aggregation, thereby potentially improving patient outcomes.

What other types of research exist?

Promising alternatives to Ifetroban for cancer patients include: 1) Patisiran, which has shown efficacy in reducing symptoms and impairment from neuropathy and improving quality of life in patients with ATTRm amyloidosis, and has potential benefits in reducing NT-proBNP levels and LV wall thickness in cardiac subgroups. 2) Inotersen, an antisense oligonucleotide that inhibits hepatic production of TTR, reducing symptoms and impairment from neuropathy. Both drugs have shown potential in improving quality of life and may offer benefits in reducing cancer metastasis through different mechanisms.

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Thromboxane A2 Receptor Antagonist

Ifetroban for Preventing Cancer Spread

Phase 2

Waitlist Available

Led By Ingrid Mayer, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be 18 years of age or older

Current diagnosis of any stage I to III malignant solid tumor at high risk of metastatic recurrence

Must not have

Evidence of biopsy-proven distant metastatic disease after completion of standard treatment

Current use of anti-platelet drugs or anticoagulants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include bleeding risks due to Ifetroban's effect on platelets, as well as possible digestive issues like ulcers or gastrointestinal bleeds which are reasons for exclusion from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My solid tumor is at high risk of spreading to other body parts.

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My kidney function is within the required range.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently taking medication to prevent blood clots.

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I do not have recent serious heart problems.

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I have a history of severe stomach issues or bleeding disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 2 trial • 57 Patients • NCT03962855

17%

Diarrhea

14%

Headache

14%

Nausea

14%

Fatigue

10%

Abdominal Pain

Bone Pain

Non-cardiac chest pain

Pharyngitis

Dyspepsia

AST increased

Nasal congestion

Epistaxis

ALT increased

Arthralgia

Dizziness

Dyspnea

Ecchymosis

Hypoglycemia

Insomnia

Myalgia

Maculopapular rash

Situational syncope

Urinary tract infection

Urinary urgency

Bloating

100%

80%

60%

40%

20%

Study treatment Arm

Ifetroban

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 (ifetroban)Experimental Treatment1 Intervention

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

Group II: Group 2 (placebo)Placebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ifetroban Sodium

2019

Completed Phase 2

~60

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cancer treatments often target specific mechanisms to inhibit tumor growth and spread. Ifetroban, for example, reduces platelet aggregation, which is crucial because cancer cells can use platelets to metastasize. By making platelets less 'sticky,' Ifetroban may help prevent cancer cells from spreading to other parts of the body. Other common treatments include chemotherapy, which kills rapidly dividing cells; targeted therapy, which blocks specific molecules involved in cancer growth; and immunotherapy, which boosts the body's immune system to fight cancer. Understanding these mechanisms helps tailor treatments to individual patients, potentially improving outcomes and reducing side effects.

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