Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer

Inclusion Criteria:

   - Histologically or cytologically documented epithelial ovarian cancer, primary
   peritoneal carcinoma, or fallopian tube cancer

   - Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin,
   or another organoplatinum compound).

   - Evidence of platinum-resistant disease, relapse/progression within 6 months of the
   completion of PBT, or intolerant to PBT (inability to receive PBT due to
   hypersensitivity reactions to platinum)

   - Patients with primary platinum-resistant disease are allowed to receive no more than
   one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the
   management of recurrent or persistent disease after the development of primary
   platinum-resistance.

   - Measurable disease per GOG-RECIST criteria

   - GOG Performance Status of 0 or 1

Exclusion Criteria:

   - Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3
   weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of
   treatment.

   - Monoclonal antibody therapy within 4 weeks prior to clinical study entry

   - Unresolved or impending bowel obstruction

   - Other active malignancies or other malignancies within the last 12 months except
   nonmelanoma skin cancer or cervical intraepithelial neoplasia

   - Prior radiotherapy to more than 25% of the marrow space

   - Requiring hemodialysis or peritoneal dialysis

   - Myocardial infarction or cerebrovascular accident/transient ischemic attack within the
   6 months prior to the anticipated first day of treatment

   - Thromboembolic event (deep vein thrombosis [DVT] or pulmonary embolus [PE]) within 28
   days prior to the anticipated first day of treatment

   - History of active CNS metastases

   - Any other medical, psychological, or social condition that would contraindicate the
   patient's participation in the clinical study due to safety or compliance with
   clinical study procedures.

Please note: There are additional inclusion/exclusion criteria for this study. Please
contact the study center for additional information and to determine if you meet all study
criteria.