Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

August 31, 2012

Study Completion Date

October 31, 2012

Conditions
Epithelial Ovarian Cancer
Interventions
DRUG

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.

Trial Locations (5)

11718

Schwartz Gynecologic Oncology, Brightwaters

21205

Johns Hopkins University, Baltimore

35293

University of Alabama at Birmingham Medical Center, Birmingham

37403

Chattanooga GYN Oncology, Chattanooga

78550

International Beneficence Clinical Research, LLC, Harlingen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Morphotek

INDUSTRY