Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.

Key Inclusion Criteria:

Women between the age of 18 and 78, inclusive;
Evidence of platinum-sensitive ovarian cancer following the patient's primary treatment(>= 6 months);
Received a 2nd line platinum-based chemotherapy regimen (4-6 cycles) without evidence of progression;
May have measurable or unmeasurable disease;
Eastern Cooperative Oncology Group (ECOG) 0 or 1;
Ability to understand and the willingness to sign a written informed consent document.

Key Exclusion Criteria:

Women who are pregnant or lactating;
Prior treatment with a topoisomerase inhibitor;
Patients with unacceptable organ and/or hematologic reserve at screening;
Urine protein of > 500 mg/day or active nephropathy;
Electrocardiogram (ECG) with evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator;
History of pancreatitis within the last 12 months;
Patients treated with previous high dose chemotherapy or stem cell transplant within the last 5 years;
Use of any investigational agents within 4 weeks of study enrollment;
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, psychiatric illness or other co-morbidity that presents a risk to the patient as determined by the investigator.