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.
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.
Jonathan S Berek, MD, MMS
Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center
United States: Food and Drug Administration
|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|