Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694249
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Drug: Ifetroban Sodium Other: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Arm Intervention/treatment
Experimental: Group 1 (ifetroban)
ifetroban capsule (250mg) will be taken by mouth daily.
Drug: Ifetroban Sodium
Given by mouth

Placebo Comparator: Group 2 (placebo)
Placebo capsule (250mg) will be taken by mouth daily.
Other: Placebo
Given by mouth




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 30 days after completing treatment ]
  2. 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). [ Time Frame: Up to 12 months ]
  3. Summarized change of FACT-G score (scale = 0 to 4) [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Percentage of patients within metastatic recurrence (within each cohort) [ Time Frame: At 12 months ]
  2. Event-free survival (within each cohort) [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694249


Contacts
Layout table for location contacts
Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 cip@vanderbilt.edu

Locations
Layout table for location information
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt-Ingram Service for Timely Access    800-811-8480    cip@vanderbilt.edu   
Principal Investigator: Ingrid Mayer, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Cumberland Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Ingrid Mayer, MD Vanderbilt-Ingram Cancer Center
Layout table for additonal information
Responsible Party: Ingrid Mayer, MD, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT03694249    
Other Study ID Numbers: VICC MD1854
NCI-2018-01930 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Ifetroban
Platelet Aggregation Inhibitors