Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
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|ClinicalTrials.gov Identifier: NCT03694249|
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Solid Tumor||Drug: Ifetroban Sodium Other: Placebo||Phase 2|
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.
I. To assess rate of metastatic recurrence after completion of ifetroban in patients with malignant solid tumors.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 2022|
|Estimated Study Completion Date :||January 2023|
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.
Given by mouth
- Incidence of adverse events [ Time Frame: 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). [ Time Frame: Up to 12 months ]
- Summarized change of FACT-G score (scale = 0 to 4) [ Time Frame: Up to 12 months ]
- Percentage of patients within metastatic recurrence (within each cohort) [ Time Frame: At 12 months ]
- Event-free survival (within each cohort) [ Time Frame: Up to 12 months ]
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
|Contact: Vanderbilt-Ingram Service for Timely Accessfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 email@example.com|
|Principal Investigator: Ingrid Mayer, MD|
|Principal Investigator:||Ingrid Mayer, MD||Vanderbilt-Ingram Cancer Center|