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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07370818
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer \[High-grade serous carcinoma (HGSC), Grade 2/3 endometrioid carcinoma\]
* Patients whose BRCA 1/2 gene mutation status and/or Homologous Recombination Deficiency (HRD) status.
* Patients who received platinum-based chemotherapy followed by PARP inhibitor maintenance therapy,
* Patients who had received chemotherapy before participating in the clinical trial and responded to platinum-based chemotherapy.
* Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Individuals with confirmed adequate hematological, renal, and hepatic function (laboratory tests may be repeated once during the screening period)
Exclusion Criteria:
* Patients with a history of severe drug hypersensitivity or hypersensitivity to the investigational drug, its components, or drugs within the same class.
* Individuals with dysphagia
* Patients with a confirmed specific medical history or a past surgical history.
* Patients with specific comorbidities or medical abnormalities.
* Pregnant women, lactating women, or women of childbearing potential who do not agree to use appropriate contraception during the clinical trial period and for 24 weeks after administration of the investigational medicinal product.
* Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
* Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT07370818
Study Brief:
Protocol Section:
NCT07370818