A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

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