NCT04339140

Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer

A Phase 2 Study of Zafirlukast for the Treatment of Tumor-marker Only Relapsed Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating the effectiveness of Zafirlukast to prevent tumor activity in participants with tumor marker-only relapsed ovarian cancer. * The name of the study drug involved in this study is: * Zafirlukast

Detailed description

This is a single-arm Simon two-stage phase 2 clinical trial to determine whether zafirlukast reduces the tumor marker CA-125 as well the tendency to form blood clots in tumor marker-only relapsed ovarian cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * The name of the study drug involved in this study is: * Zafirlukast Eligible participants will receive study treatment for up to 1 year and will be followed for up to one year following treatment. It is expected that about 30 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved zafirlukast for this specific disease but it has been approved for other uses. Zafirlukast is currently approved to be used for the treatment of asthma. It has been recently learned that Zakfirlukast demonstrates anti-tumor activity in laboratory studies of ovarian cancer. This means that these results were not found in humans. The National Institutes of Health are supporting this research study by providing funding

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Zafirlukast	Oral tablets, 2x daily for 28 day cycle up to 1 year

Timeline

• Start date: 2020-06-24
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2020-04-09
• Last updated: 2025-12-11
• Results posted: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study