Status:
WITHDRAWN
Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.
Lead Sponsor:
NewLink Genetics Corporation
Conditions:
Cancer
Ovarian Cancer
Eligibility:
FEMALE
18-78 years
Phase:
PHASE2
Brief Summary
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00753740
Start Date
September 1 2008
End Date
May 1 2010
Last Update
June 12 2020
Active Locations (7)
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1
Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois
Decatur, Illinois, United States, 62526
2
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
3
Schwartz Gynecologic Onclology, PLLC
Brightwaters, New York, United States, 11718
4
Gabrail Cancer Center
Canton, Ohio, United States, 44718