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A Randomized Study of MORAb-003 (Farletuzumab) Plus Paclitaxel in Patients with Platinum-Resistant or Refractory Relapsed Ovarian Cancer
[Protocol 08-149]
- Full Title :
- A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF MORAB-003 (FARLETUZUMAB) IN COMBINATION WITH PACLITAXEL THERAPY IN SUBJECTS WITH PLATINUM-RESISTANT OR REFRACTORY RELAPSED OVARIAN CANCER
- Purpose :
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called MORAb-003 (also called farletuzumab) in combination with paclitaxel in women with ovarian cancer that has persisted or worsened despite receiving platinum-based chemotherapy.
MORAb-003 is a monoclonal antibody against a vitamin receptor that is found in high amounts on ovarian cancer cells. The binding of MORAb-003 to the receptor causes the death of tumor cells and/or slows down their growth.
Two-third of the women in this study will be randomly assigned to receive MORAb-003 plus paclitaxel, while the remaining third will receive paclitaxel alone.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of ovarian cancer that has persisted or worsened during or within 6 months of receiving platinum-based chemotherapy.
- Patients may have had one or two regimens of chemotherapy, at least one of which also included a taxane.
- At least 3 weeks must have passed since completion of prior chemotherapy and entry into the study.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Jason Konner at 212-639-8151.
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