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Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer

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

NCT04339140•Beth Israel Deaconess Medical Center

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.
•Participants must have completed at least first-line platinum based chemotherapy and surgery with a response, in the opinion of the investigator, defined as no evidence of disease progression or rising CA-125 at any time during front-line treatment.
•Participants must meet criteria for tumor marker-only relapse, defined as CA-125 more than twice the upper limit of normal (35 U/mL) in the setting of a normal baseline CA-125 levels or CA-125 greater than twice the nadir count on two successive measurements for CA-125 values that remain above baseline without measurable radiographic disease.
•Minimum age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of zafirlukast in participants under 18 years of age with ovarian cancer, children are excluded from this study but will be eligible for future pediatric trials.
•Life expectancy of greater than 4 months.
•ECOG performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix A).
•Participants must be able to swallow tablets.
•Participants must have adequate organ and marrow function as defined below:
•* Absolute neutrophil count ≥1,000/mcL
•* Platelets ≥100,000/mcL
+4 more criteria

Exclusion Criteria

•Ability to understand and the willingness to sign a written informed consent document
•Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie borderline tumors) or mucinous tumors. Mixed mullerian tumors or carcinosarcomas are allowed.
•Participants who have had cytotoxic chemotherapy including bevacizumab or radiotherapy within 4 weeks prior to entering the study. This does not include maintenance therapy (\>8 weeks prior to enrollment of stable dose) with a PARP inhibitor, such as olaparib or niraparib. (PARP inhibitor, rucaparib is not allowed to be co-administered with CYP2C9 substrates as maintenance therapy as it could increase exposure to zafirlukast).
•Participants who have ongoing adverse effects from prior anti-cancer therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v5.0) Grade 1, with the exception of Grade 2 non-hematologic toxicity such as alopecia and peripheral neuropathy.
•Participants who are receiving any other investigational agents.
•Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to zafirlukast.
•Currently receiving anticoagulant therapy.
•Current daily use of aspirin (\> 81 mg daily), clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g. ibuprofen \> 800 mg daily or equivalent).
•Participants receiving any medications or substances that are inhibitors or inducers of CYP2C9 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
+3 more criteria

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

June 24, 2020

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2024

Last Updated

December 11, 2025

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

Zafirlukast

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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