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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT00429559
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed ovarian adenocarcinoma
* Patients had to have received a front-line, platinum- based chemotherapy regimen
* Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer. This category also will include patients with disease progression within six months of completing the most recent platinum-based chemotherapy
* Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca 125
* A \>= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
* Age \> 18 years old
* Performance status (WHO) 0-2
* Life expectancy of at least three months
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2 mg/dl)
* Informed consent
Exclusion Criteria:
* Pregnant or nursing
* Psychiatric illness or social situation that would preclude study compliance
* Other concurrent uncontrolled illness
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00429559
Study Brief:
Protocol Section:
NCT00429559