Trial Outcomes & Findings for Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer (NCT NCT04339140)
NCT ID: NCT04339140
Last Updated: 2025-12-11
Results Overview
Response will be defined according to GCIG criteria which requires a reduction of CA-125 of \> 50% relative to pre-treatment CA-125 level, maintained for at least 28 days
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
84 days
Results posted on
2025-12-11
Participant Flow
Single-arm study. All participants received 40 mg of Zafirlukast twice daily.
Participant milestones
| Measure |
Zafirlukast
Zafirlukast will be taken orally at a pre-determined dose 2x daily for 28 day cycle up to 1 year.
Zafirlukast: Oral tablets, 2x daily for 28 day cycle up to 1 year
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Zafirlukast
n=4 Participants
Zafirlukast will be taken orally at a pre-determined dose 2x daily for 28 day cycle up to 1 year.
Zafirlukast: Oral tablets, 2x daily for 28 day cycle up to 1 year
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=237 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=237 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=237 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=237 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=237 Participants
|
PRIMARY outcome
Timeframe: 84 daysResponse will be defined according to GCIG criteria which requires a reduction of CA-125 of \> 50% relative to pre-treatment CA-125 level, maintained for at least 28 days
Outcome measures
| Measure |
Zafirlukast
n=4 Participants
Zafirlukast will be taken orally at a pre-determined dose 2x daily for 28 day cycle up to 1 year.
Zafirlukast: Oral tablets, 2x daily for 28 day cycle up to 1 year
|
|---|---|
|
CA-125 Response Rate
|
0 Participants
|
Adverse Events
Zafirlukast
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zafirlukast
n=4 participants at risk
Zafirlukast will be taken orally at a pre-determined dose 2x daily for 28 day cycle up to 1 year.
Zafirlukast: Oral tablets, 2x daily for 28 day cycle up to 1 year
|
|---|---|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1 • 1 year
CTCAE v. 5
|
|
General disorders
Abdominal Pain
|
75.0%
3/4 • Number of events 3 • 1 year
CTCAE v. 5
|
|
Blood and lymphatic system disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • 1 year
CTCAE v. 5
|
|
General disorders
Abdominal Bloating
|
25.0%
1/4 • Number of events 1 • 1 year
CTCAE v. 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place