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:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04893551
Eligibility Criteria:
Inclusion Criteria:
* Females of non-childbearing potential at the time of provision of informed consent
* Ability to understand and provide written confirmation of informed consent after reading study information, discussion with the investigator, and adequate time to decide on participation
* Consents to storage of study-related samples and data for exploratory use
* Histologically confirmed HGSOC
* Platinum-resistant relapsed disease; defined as progressive disease based on imaging within \<= 6 months from completion of most recent regimen
Exclusion Criteria:
* Primary platinum-refractory disease (ie, progression during the first platinum regimen or within 4 weeks of completion of the first platinum regimen) with rapid progression and life-threatening disease manifestation
* Life expectancy \< 6 months
* Concurrent anticancer therapy
* Participants who are breastfeeding
* Known uncontrolled central nervous system metastases. Participants without known brain metastases do not require radiological imaging prior to enrolment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04893551
Study Brief:
Protocol Section:
NCT04893551