Clinical Trials /

Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence

NCT03694249

Description:

This pilot trial studies the side effects of ifetroban in treating patients with malignant solid tumors that are at high risk of coming back after treatment and spreading throughout the body. Platelets are a type of blood cells that help with clotting. Cancer cells stick to platelets and ride on them to get to different parts of the body. 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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
  • Official Title: A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence

Clinical Trial IDs

  • ORG STUDY ID: VICC MD1854
  • SECONDARY ID: NCI-2018-01930
  • NCT ID: NCT03694249

Conditions

  • Malignant Solid Tumor

Interventions

DrugSynonymsArms
Ifetroban SodiumGroup 1 (ifetroban)

Purpose

This pilot trial studies the side effects of ifetroban in treating patients with malignant solid tumors that are at high risk of coming back after treatment and spreading throughout the body. Platelets are a type of blood cells that help with clotting. Cancer cells stick to platelets and ride on them to get to different parts of the body. 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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess the safety and feasibility of ifetroban sodium (ifetroban) administration in
      patients with malignant solid tumors at high risk of metastatic recurrence, after completion
      of all planned (neo)adjuvant locoregional and systemic therapies.

      SECONDARY OBJECTIVES:

      I. To assess rate of metastatic recurrence after completion of ifetroban in patients with
      malignant solid tumors.

      EXPLORATORY OBJECTIVES:

      I. To quantify pharmacodynamic markers of ifetroban effects.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP 1 (IFETROBAN): Patients receive ifetroban sodium orally (PO) once daily (QD). Courses
      repeat every 28 days for 12 months in the absence of disease progression or unacceptable
      toxicity.

      GROUP 2 (PLACEBO): Patients receive a placebo PO QD. Courses repeat every 28 days for 12
      months in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 days, then up to 12
      months.
    

Trial Arms

NameTypeDescriptionInterventions
Group 1 (ifetroban)Experimentalifetroban capsule (250mg) will be taken by mouth daily.
  • Ifetroban Sodium
Group 2 (placebo)Placebo ComparatorPlacebo capsule (250mg) will be taken by mouth daily.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Signed and dated written informed consent.
    
              -  Subjects ≥ 18 years of age
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
    
              -  Current diagnosis of any stage I to III malignant solid tumor at high risk of
                 metastatic recurrence (deemed by treating physician as patients with ≥ 50% chance of
                 cancer metastatic recurrence within 5 years of diagnosis)
    
              -  Patients must have completed all standard locoregional and systemic therapy for their
                 cancer within 120 days of study enrollment.
    
              -  Administration of an investigational agent prior to enrollment needs to be completed
                 at least 30 days prior to enrollment
    
              -  Patients must have recovered (≤ grade 1 toxicities or grade 2 toxicities well managed
                 with optimal medical care) from effects of local (surgery, radiation) or systemic
                 treatments.
    
              -  Platelet count ≥ 100,000 per mL of blood
    
              -  Hemoglobin ≥ 9/g/dL (may have been transfused)
    
              -  Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as
                 calculated using the Cockcroft-Gault (CG) equation
    
              -  Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
    
              -  Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 ×
                 ULN
    
              -  INR below upper limit of normal (ULN)
    
              -  Female patients of childbearing potential and non-sterile males must agree to use at
                 least two methods of acceptable contraception from 15 days prior to first trial
                 treatment administration until at least 5 months after study participant's final dose
                 of study drug
    
            Note: Females of childbearing potential are defined as those who are not surgically sterile
            or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral
            oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without
            an alternative medical cause). Post-menopausal status in females under 55 years of age
            should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory
            reference range for postmenopausal women. Non-sterile males are those who have not had a
            vasectomy with documentation of the absence of sperm in the ejaculate.
    
              -  Patients unable to read/write in English are eligible to participate in the overall
                 study but will not participate in the Patient-Reported Outcome questionnaires
                 throughout the trial.
    
              -  Re-enrollment of a subject that has discontinued the study as a pre-treatment screen
                 failure (i.e. a consented patient who did not receive study drugs) is permitted. If
                 reenrolled, the subject must be re-consented. Only the screening procedures performed
                 outside of protocol-specified timing must be repeated.
    
            Exclusion Criteria:
    
              -  Evidence of biopsy-proven distant metastatic disease after completion of standard
                 treatment
    
              -  Current use of anti-platelet drugs (ASA, NSAIDs, clopidogrel, argatroban, etc.) or
                 anticoagulants (warfarin, heparin products, etc.)
    
              -  Active malignancy within 5 years prior to current diagnosis except for in situ disease
                 or cancer with very high curability rate (i.e. testicular cancer, etc.)
    
              -  Uncontrolled co-morbid serious systemic illnesses that in the opinion of the
                 investigator could compromise therapeutic safety.
    
              -  No concurrent anticancer therapy. Required washout from prior therapy:
    
                   -  Chemotherapy: 21 days
    
                   -  Major surgery: 14 days (provided wound healing is adequate)
    
                   -  Radiation: 7 days
    
                   -  Investigational/Biologic Therapy: 30 days
    
              -  Current symptomatic congestive heart failure (New York Heart Association > class II),
                 unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable
                 angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled
                 hypertension (systolic > 160 mmHg or diastolic > 100mmHg). Or any of the following
                 occurring within 6 months (180 days) prior to first dose of study drugs: Myocardial
                 infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or
                 transient ischemic attack. (Use of antihypertensive medication to control blood
                 pressure is allowed.)
    
              -  Ongoing peptic ulcer disease requiring treatment
    
              -  History of gastrointestinal bleed
    
              -  Severe gastro-esophageal reflux disease requiring treatment
    
              -  History of bleeding diathesis
    
              -  Planned elective major surgical intervention while taking ifetroban
    
              -  Pregnant or breastfeeding females.
    
              -  Prisoners or subjects who are involuntarily incarcerated.
    
              -  Known psychiatric condition, social circumstance, or other medical condition
                 reasonably judged by the patient's study physician to unacceptably increase the risk
                 of study participation; or to prohibit the understanding or rendering of informed
                 consent or anticipated compliance with scheduled visits, treatment schedule,
                 laboratory tests and other study requirements.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence of adverse events
    Time Frame:Up to 30 days after completing treatment
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Percentage of patients within metastatic recurrence (within each cohort)
    Time Frame:At 12 months
    Safety Issue:
    Description:
    Measure:Event-free survival (within each cohort)
    Time Frame:Up to 12 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Vanderbilt-Ingram Cancer Center

    Last Updated

    March 5, 2020