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

This is an interventional treatment trial for Malignant Solid Tumor Read More

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
• 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.