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

NCT03694249 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: VICC MD1854NCI-2018-01930
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Up to 30 days after completing treatment

• 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).

  Up to 12 months

• Summarized change of FACT-G score (scale = 0 to 4)

  Up to 12 months

Secondary Outcomes (2)

• Percentage of patients within metastatic recurrence (within each cohort)

  At 12 months

• Event-free survival (within each cohort)

  Up to 12 months

Study Arms (2)

Group 1 (ifetroban)

EXPERIMENTAL

ifetroban capsule (250mg) will be taken by mouth daily.

Drug: Ifetroban Sodium

Group 2 (placebo)

PLACEBO COMPARATOR

Placebo capsule (250mg) will be taken by mouth daily.

Other: Placebo

Interventions

Ifetroban Sodium DRUG

Given by mouth

Group 1 (ifetroban)

Placebo OTHER

Given by mouth

Group 2 (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• Cumberland Pharmaceuticals: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

• Sonya Reid, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 3, 2018
• Study Start: December 12, 2018
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

US (1)