15
Participants
Start Date
November 30, 2009
Primary Completion Date
August 31, 2012
Study Completion Date
October 31, 2012
Farletuzumab, Carboplatin, and PLD
All subjects will receive approximately 6 cycles with carboplatin (AUC5-6) i.v. and PLD (30 mg/m2) i.v. on Day 1 of every 4-week Combination treatment cycle. In addition, subjects will also receive weekly farletuzumab at 2.5 mg/kg administered i.v. Following completion of the Combination treatment period (carboplatin/PLD/farletuzumab therapy),maintenance treatment with single agent farletuzumab will be administered once Q3W at 7.5 mg/kg until disease progression as defined by GCIG CA-125 (i.e., CA-125 is less than or equal to 2 × (ULN) documented on 2 occasions) or modified RECIST v.1.0 using CT or MRI.
Schwartz Gynecologic Oncology, Brightwaters
Johns Hopkins University, Baltimore
University of Alabama at Birmingham Medical Center, Birmingham
Chattanooga GYN Oncology, Chattanooga
International Beneficence Clinical Research, LLC, Harlingen
Lead Sponsor
Morphotek
INDUSTRY