A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer
Farletuzumab (MORAb-003) is a monoclonal antibody that has the potential to be an effective
agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal
adenocarcinoma) in combination with other drugs. Farletuzumab works by a different mechanism
from other cancer therapeutics and has been shown to be well tolerated. This study allows
the opportunity to determine if the combination therapy of farletuzumab, carboplatin, and
1. is safe, or
2. to assess the potential drug-drug interaction, and
3. to prolong response to chemotherapy.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.
At all study visits.
Susan Weil, MD
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|Chattanooga GYN Oncology||Chattanooga, Tennessee 37403|
|Schwartz Gynecologic Oncology||Brightwaters, New York 11718|
|University of Alabama at Birmingham Medical Center||Birmingham, Alabama 35233|
|International Beneficence Clinical Research, LLC||Harlingen, Texas 78550|