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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT02399592
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
* Prior treatment with at least two different cytostatic regimens including platinum.
* Progression on previous treatment.
* Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.
* Age ≥ 18 years.
* Performance stage 0-2.
* Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
* WBC ≥ 3.0 \* 10\^9/l or neutrophils (ANC) ≥ 1.5 \* 109/l
* Platelet count ≥ 100 \* 10\^9/l
* Hemoglobin ≥ 6 mmol/l
* Serum bilirubin \< 2.0 \* ULN
* Serum transaminase ≤ 2.5 \* ULN
* Serum creatinine ≤ 1.5 ULN
* Urine dipstick for protein \<2+. If the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents \< 1 g.
* Written informed consent.
Exclusion Criteria:
* Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
* Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
* Underlying medical disease not adequately treated (diabetes, cardiac disease).
* Uncontrolled hypertension (BT \>150/100 despite antihypertensive treatment).
* Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.
* Non-healing wounds or fractures.
* Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment.
* Clinically significant cardiovascular disease, including:
* Myocardial infarction or unstable angina within 6 months before start of treatment
* New York heart Association (NYHA) class ≥ 2
* Poorly controlled cardiac arrhythmia despite medication
* Periferal vascular disease grade ≥ 3
* Allergy to the active substance or any of the auxiliary agents
* Bleeding tumor
* Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
* Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02399592
Study Brief:
Protocol Section:
NCT02399592