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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT01033292
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma
* Completion of only one previous course of chemotherapy which contained a platinum therapy, with resistance to that regimen. "Platinum-resistance" is defined by a relapse within 2 to 6 months after termination of platinum-based chemotherapy
* Measurable disease, defined by at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded), and is ≥ 20 mm when measured by conventional techniques (palpation, plain x-ray, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) or ≥ 10 mm when measured by spiral CT
* Adequate organ function defined as: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, creatinine clearance \> 50mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN; or \< 5 x ULN in case of liver metastases); total bilirubin \< 1.5 mg/dL
* For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control during the duration of the study therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Signed, institutional review board (IRB) approved written informed consent
Exclusion Criteria:
* Concurrent invasive malignancy, not including:
1. Non-melanomatous skin cancer
2. In situ malignancies
3. Concurrent superficial endometrial carcinoma, if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium)
4. Low risk breast cancer (localized, non-inflammatory) treated with curative intent
* Lesions identifiable only by positron emission tomography (PET)
* Prior treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, including BSI-201
* Major medical conditions that might affect study participation (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection)
* Other significant co-morbid condition which the investigator feels might compromise effective and safe participation in the study, including a history of congestive cardiac failure or an electrocardiogram (ECG) suggesting significant conduction defect or myocardial ischemia
* Enrollment in another investigational device or drug study, or current treatment with other investigational agents
* Concurrent radiation therapy to treat primary disease throughout the course of the study
* Inability to comply with the requirements of the study
* Pregnancy or lactation
* Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01033292
Study Brief:
Protocol Section:
NCT01033292