Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT04805333
Eligibility Criteria:
Inclusion Criteria:
* Able to understand and willing to sign a written informed consent document.
* Age ≥ 18 years.
* Patients diagnosed with Stage II-IV ovarian cancer who have completed initial first-line therapy with carboplatin and paclitaxel and achieved a complete response.
* Creatinine clearance ≥ 60 mL/min
* Total bilirubin ≤ 1.5 x ULN, and AST and ALT ≤ 3.0 x ULN
* GOG Performance Status ≤ 2.
Exclusion Criteria:
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study visits, in the opinion of the treating physician.
* Pregnant women are excluded from this study.
* Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin
* Women with active gastric ulcers are excluded from this study.
* Patients who are receiving concurrent maintenance therapy with a PARP inhibitor for a known hereditary recombinant deficiency (HRD) mutation. Bevacizumab maintenance therapy is allowed.
* Concurrent use of nevirapine, ritonavir and strong UGT inhibitors or inducers.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04805333
Study Brief:
Protocol Section:
NCT04805333