A Phase II Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of Maintenance IT-101 in Platinum Sensitive Ovarian Cancer Patients Who Received 4-6 Cycles of a 2nd Line Platinum-Based Regimen Without Disease Progression.

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;

- 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.