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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights

Study Summary

This trial is testing ifetroban to see if it can help reduce the spread of cancer cells by making platelets less "sticky."

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to treatment (participants will be provided a pill diary to record when they take their medication. Study staff will collect the pill diary from participants at their clinic visits).
Incidence of adverse events
Summarized change of FACT-G score (scale = 0 to 4)
Secondary outcome measures
Event-free survival (within each cohort)
Percentage of patients within metastatic recurrence (within each cohort)

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.

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,903 Total Patients Enrolled
Cumberland PharmaceuticalsIndustry Sponsor
62 Previous Clinical Trials
9,433 Total Patients Enrolled
Ingrid Mayer, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center
11 Previous Clinical Trials
314 Total Patients Enrolled

Media Library

Ifetroban Sodium (Thromboxane A2 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03694249 — Phase 2
Cancer Research Study Groups: Group 1 (ifetroban), Group 2 (placebo)
Cancer Clinical Trial 2023: Ifetroban Sodium Highlights & Side Effects. Trial Name: NCT03694249 — Phase 2
Ifetroban Sodium (Thromboxane A2 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03694249 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively engaged in this research project?

"Affirmative. According to clinicaltrials.gov, this medical experiment is currently recruiting participants, with the original postdate of December 12th 2018 and last updated on June 23rd 2022. 60 patients are needed from a single site for this trial."

Answered by AI

What other research projects have been conducted with Ifetroban Sodium as the primary agent?

"Presently, there are 4 active clinical trials for Ifetroban Sodium with none at the Phase 3 stage. The bulk of these studies are located in Nashville, Tennessee while a total of 30 sites offer access to it."

Answered by AI

Has the Federal Drug Administration sanctioned Ifetroban Sodium?

"Our team at Power assessed Ifetroban Sodium's safety as a 2, given that this is Phase 2 of the trial, with limited data regarding its efficacy but some information available on its safety."

Answered by AI

Are there any enrollment opportunities in this trial presently?

"According to the clinicialtrials.gov page, this trial is currently seeking participants. It was first introduced on December 12th of 2018 and was updated most recently on June 23rd 2022."

Answered by AI

Is this experiment an unprecedented clinical endeavor?

"Since its initial trial in 2017, sponsored by Cumberland Pharmaceuticals and involving 76 patients, Ifetroban Sodium has progressed to Phase 2 drug approval. Currently there are 4 ongoing studies of the medication being conducted across 27 cities and 1 nation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
Sonya Reid 2018. "Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03694249.
~0 spots leftby Jun 2024
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