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

• Status: Withdrawn
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cerulean Pharma Inc.; NewLink Genetics Corporation
• Treatments: Camptothecin

Criteria

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.