NCT03694249

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

A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	Ifetroban Sodium	Given by mouth
OTHER	Placebo	Given by mouth

Timeline

• Start date: 2018-12-12
• Primary completion: 2025-04-01
• Completion: 2026-04-01
• First posted: 2018-10-03
• Last updated: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study