E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125

Exclusion Criteria

• •Participants will not be entered in the study for any of the following reasons:
• •1. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures;
• •2. Prior anti-angiogenic therapy with anti-VEGFR inhibitors; bevacizumab is allowed;
• •3. Prior gemcitabine;
• •4. Participants with proteinuria greater than 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with 24-hour urine protein greater than or equal to 1 g/24 hours will be ineligible.
• •5. Ovarian nonepithelial cancer, including malignant mixed Mullerian tumors and borderline tumors (e.g., tumors of low malignant potential);
• •6. Other malignancy within 5 years of randomization, with the exception of adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer, with no subsequent evidence of recurrence;
• •7. History of, or known carcinomatous meningitis;
• •8. Are currently receiving any other treatment for the tumor (including palliative radiotherapy) aside from control of symptoms;
• •9. Received treatment in another clinical study within the 30 days prior to commencing study treatment or participants who have not recovered from side effects of an investigational drug to Grade less than or equal to 1, except for peripheral neuropathy (Grade 1 or 2 are permitted) or alopecia;
• •10. Received chemotherapy, biological therapy, hormonal therapy, targeted therapy, or radiotherapy within the 30 days prior to commencing study treatment or have not recovered from all treatment-related toxicities to Grade less than or equal to 1, except for peripheral neuropathy (Grade 1 or 2 are permitted) or alopecia;
• •11. Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment. Minor surgery such as Portacath placement or skin biopsy is permitted if greater than or equal to 7 days have passed;
• •12. The use of anti-coagulants such as Vitamin K antagonists, unfractionated heparin, or low molecular weight heparin;
• •13. Refractory nausea and vomiting, malabsorption, significant bowel resection, or any other medical condition that would preclude adequate absorption or result in the inability to take oral medication;
• •14. Significant cardiovascular impairment (history of congestive heart failure) New York Heart Association (NYHA) Grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
• •15. Any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) unless they have had no evidence of active disease for at least 6 months prior to randomization
• •16. Active hemoptysis (defined as bright red blood of 1/2 teaspoon or more) within the 30 days prior to study entry;
• •17. History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess within the 6 months prior to enrolment;
• •18. History of bleeding diathesis or coagulopathy;
• •19. History of an allograft requiring immunosuppression;
• •20. Known positive human immunodeficiency virus (HIV), known surface antigen positive for hepatitis B hepatitis or C positive;
• •21. Hypersensitivity to E7080 and/or E7080 chemical derivative; or
• •22. Have any other uncontrolled infection or medical condition which would interfere with the conduct of the study.