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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT01630018
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Histological or cytological diagnosis of AOC
* Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line therapy
* Measurable disease defined by RECIST criteria
* ECOG Performance Status of 0, 1, or 2
* Life expectancy \> 3 months
* Adequate bone marrow, Renal, Hepatic reserve:
* absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL
* platelet count ≥ 100,000 cells/μL
* hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 X ULN
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN
* Alkaline Phosphatase (ALP) ≤ 2.0 X ULN
* Serum creatinine \< 1.5mg/dL or calculated creatinine clearance \> 60mL/min
* Signed a written informed consent
Exclusion Criteria:
* Active infection
* Symptomatic brain lesion
* Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix Severe concurrent diseases
* Prior anticancer therapy within 4 weeks before enroll
* Active pregnancy test and Pregnant or nursing women
* Participation in any investigational drug study within 28 days prior to study entry
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01630018
Study Brief:
Protocol Section:
NCT01630018