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Brief Title: Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer
Official Title: A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer
Study ID: NCT01004380
Brief Summary: The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.
Detailed Description: 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 PLD 1. is safe, or 2. to assess the potential drug-drug interaction, and 3. to prolong response to chemotherapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham Medical Center, Birmingham, Alabama, United States
Johns Hopkins University, Baltimore, Maryland, United States
Schwartz Gynecologic Oncology, Brightwaters, New York, United States
Chattanooga GYN Oncology, Chattanooga, Tennessee, United States
International Beneficence Clinical Research, LLC, Harlingen, Texas, United States
Name: Susan Weil, MD
Affiliation: Morphotek
Role: STUDY_DIRECTOR