Clinical trial NCT01033292 (phase 2, status: completed)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: bsi-201
SMILES: OC1=NN=C(CC2=CC(C(=O)N3CCN(CC3)C(=O)C3CC3)=C(F)C=C2)C2=CC=CC=C12
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