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:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Breast Carcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Lung Carcinoma
  • Pancreatic Adenocarcinoma
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

  • Anatomic Stage II Breast Cancer
  • Anatomic Stage IIA Breast Cancer
  • Anatomic Stage IIB Breast Cancer
  • Anatomic Stage III Breast Cancer
  • Anatomic Stage IIIA Breast Cancer
  • Anatomic Stage IIIB Breast Cancer
  • Anatomic Stage IIIC Breast Cancer
  • Clinical Stage II Esophageal Adenocarcinoma
  • Clinical Stage II Esophageal Squamous Cell Carcinoma
  • Clinical Stage II Gastric Cancer
  • Clinical Stage II Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IIA Esophageal Adenocarcinoma
  • Clinical Stage IIA Gastric Cancer
  • Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IIB Esophageal Adenocarcinoma
  • Clinical Stage IIB Gastric Cancer
  • Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage III Esophageal Adenocarcinoma
  • Clinical Stage III Esophageal Squamous Cell Carcinoma
  • Clinical Stage III Gastric Cancer
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma
  • Distal Esophagus Squamous Cell Carcinoma
  • Esophageal Carcinoma
  • Estrogen Receptor Negative
  • HER2/Neu Negative
  • Limited Stage Small Cell Lung Carcinoma
  • Malignant Solid Neoplasm
  • Non-Small Cell Lung Carcinoma
  • Pancreatic Adenocarcinoma
  • Pathologic Stage II Esophageal Adenocarcinoma
  • Pathologic Stage II Esophageal Squamous Cell Carcinoma
  • Pathologic Stage II Gastric Cancer
  • Pathologic Stage II Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIA Esophageal Adenocarcinoma
  • Pathologic Stage IIA Esophageal Squamous Cell Carcinoma
  • Pathologic Stage IIA Gastric Cancer
  • Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIB Esophageal Adenocarcinoma
  • Pathologic Stage IIB Esophageal Squamous Cell Carcinoma
  • Pathologic Stage IIB Gastric Cancer
  • Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage III Esophageal Adenocarcinoma
  • Pathologic Stage III Esophageal Squamous Cell Carcinoma
  • Pathologic Stage III Gastric Cancer
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIIA Esophageal Adenocarcinoma
  • Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma
  • Pathologic Stage IIIA Gastric Cancer
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIIB Esophageal Adenocarcinoma
  • Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma
  • Pathologic Stage IIIB Gastric Cancer
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIIC Gastric Cancer
  • Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma
  • Postneoadjuvant Therapy Stage II Esophageal Squamous Cell Carcinoma
  • Postneoadjuvant Therapy Stage II Gastric Cancer
  • Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma
  • Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma
  • Postneoadjuvant Therapy Stage III Gastric Cancer
  • Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma
  • Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma
  • Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma
  • Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma
  • Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma
  • Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma
  • Progesterone Receptor Negative
  • Prognostic Stage II Breast Cancer
  • Prognostic Stage IIA Breast Cancer
  • Prognostic Stage IIB Breast Cancer
  • Prognostic Stage III Breast Cancer
  • Prognostic Stage IIIA Breast Cancer
  • Prognostic Stage IIIB Breast Cancer
  • Prognostic Stage IIIC Breast Cancer
  • Stage I Pancreatic Cancer
  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage II Lung Cancer
  • Stage II Pancreatic Cancer
  • Stage IIA Lung Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Lung Cancer
  • Stage IIB Pancreatic Cancer
  • Stage III Lung Cancer
  • Stage IIIA Lung Cancer
  • Stage IIIB Lung Cancer
  • Stage IIIC Lung Cancer
  • Triple-Negative Breast Carcinoma

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.
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
    
              -  One of the following current diagnoses:
    
                   -  Stage IIa to III triple negative breast cancer (TNBC).
    
                   -  Stage I to II pancreatic adenocarcinoma.
    
                   -  Lung Cancer.
    
                        -  Stage IIa to III non-small cell lung cancer (NSCLC).
    
                        -  Limited stage small cell lung cancer (SCLC).
    
                   -  Stage IIa to III esophageal or gastroesophageal (GE) junction cancers (squamous
                      cell carcinoma [SCCA] or adenocarcinoma).
    
                   -  Stage IIa to III stomach cancer.
    
              -  Patients must have completed all standard locoregional and systemic therapy for their
                 cancer.
    
              -  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) 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 upper limit of normal (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/serum glutamic oxaloacetic transaminase [SGOT]) and
                 alanine aminotransferase (ALT/serum glutamate-pyruvate transaminase [SGPT]) =< 2.5 x
                 ULN.
    
              -  International normalized ratio (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:
    
              -  Clinical evidence of residual or distant disease after completion of standard
                 treatment.
    
              -  Current use of anti-platelet drugs (acetylsalicylic acid [ASA], nonsteroidal
                 anti-inflammatory drugs [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:Not yet recruiting
    Lead Sponsor:Vanderbilt-Ingram Cancer Center

    Last Updated