Farletuzumab in Combination with Carboplatin&Taxane in Ovarian Cancer
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse
IRAS ID
14940
Contact name
Nicholas (Nick) Reed
Contact email
Sponsor organisation
Morphotek, Inc.(a company owned by the Eisai Corporation of North America)and Eisai Limited, Please see A64-3.
Eudract number
2008-005872-29
Clinicaltrials.gov Identifier
00849667
Research summary
Ovarian cancer is the leading cause of death among women with gynecological cancers and is a disease with ongoing, significant unmet medical need. The standard therapy for advanced ovarian cancer, is surgery, followed by chemotherapy (use of drugs to treat cancer).Unfortunately, despite this, the majority of patients will relapse and long-term survival remains low. Therefore, the need to develop new therapies that may achieve long-term disease stabilisation in subjects with minimal disease states may prove important to this patient population. MORAb-003 (farletuzumab) is a monoclonal antibody (immune system protein), to the folate receptor alpha and has the potential to be an effective agent against epithelial ovarian cancer, either alone or in combination with chemotherapy. In this study we will test the hypothesis that MORAb-003 can add to the efficacy of platinum-containing chemotherapy in relapsed Ovarian Cancer and can prolong the time span of a second remission in subjects who are sensitive to platinum chemotherapy. If positive, results from this study may lead to the addition of MORAb-003 to the current standard of care. Patients will be randomised in a 1:1:1 ratio in 3 parallel groups to two doses of MORAb-003 or placebo in combination with carboplatin and taxane. Participants will receive MORAb-003 or placebo weekly throughout the study.CT (Computed Tomography) or MRI (Magnetic Resonance Imaging)scans will be performed during treatment to assess the tumor. Treatment will continue until evidence of radiographic progression (the cancer starts growing again), until the participant experiences intolerable toxicities or until the participant withdraws from the study. Participants who discontinue study treatment will be followed for survival monthly for 9 months then approximately every 2 months until death or study termination by the Sponsor. This study will be sponsored by Morphotek, Inc.(a company owned by the Eisai Corporation of North America)and Eisai Limited.A Total of 900 patients will be enrolled at up to 300 sites in approximately 32 countries.
REC name
West of Scotland REC 1
REC reference
09/S0703/71
Date of REC Opinion
4 Aug 2009
REC opinion
Further Information Favourable Opinion