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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT03480750
Eligibility Criteria:
Inclusion Criteria:
* Histologically proved epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer after surgical staging or debulking surgery
* The first relapse within 1 year after the completion of primary platinum-based chemotherapy (partially platinum-resistant/-sensitive) or disease progression during primary chemotherapy (platinum-refractory).
* Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
* Adequate bone marrow function (absolute neutrophil count ≥ 1,500/μl, hemoglobin ≥ 9.0 g/dL and platelet count ≥ 100,000/μl)
* Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of at least 50 mL/min, total serum bilirubin ≤ 5.0 mg/dL
* Alanine transaminase (ALT) or aspartate aminotransferase (AST) ≤ 5 × upper normal limit
* Patients with reproductive potential had to agree to use an effective method of birth control prior to study entry for the duration of the study participation
* If there was no available therapy that prolonged survival for at least 3 months
Exclusion Criteria:
* Patients who have metastasis to the central nervous system
* Patients who have other malignancies within 5 years prior to study entry with the exception of carcinoma in situ of the cervix uteri and non-melanoma skin cancers
* Patients who are receiving concurrent chemotherapy
* Patients who have not recovered from surgery within 4 weeks of the study;
* Patients with a clinically significant medical condition that could be aggravated by treatment or that cannot be controlled
* Patients with medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk
* Patients with known anaphylactic response or severe hypersensitivity to study drugs or their analogs
* Pregnant or lactating women
* Patients with any evidence of difficulty swallowing, intestinal obstruction or malabsorption disorder interfering with nutrition
* Patients who were unwilling or unable to provide informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT03480750
Study Brief:
Protocol Section:
NCT03480750