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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To Compare the proportion of patients without evidence of disease progression at 30 weeks following randomization between IT-101 at 12 mg/m2/dose or 15 mg/m2/dose to a placebo infusion treatment administered every other week.
30 weeks
No
Jonathan S Berek, MD, MMS
Principal Investigator
Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center
United States: Food and Drug Administration
ID OVAR0801
NCT01565421
September 2008
May 2010
Name | Location |
---|---|
Gabrail Cancer Center | Canton, Ohio 44718 |
The Methodist Hospital | Houston, Texas 77030 |
Chattanooga GYN Oncology | Chattanooga, Tennessee 37403 |
University of Minnesota Medical Center | Minneapolis, Minnesota 55455 |
Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois | Decatur, Illinois 62526 |
Schwartz Gynecologic Onclology, PLLC | Brightwaters, New York 11718 |
Riverside Gynecology & Oncology | Newport News, Virginia 23601 |