Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ovarian Cancer

In brief

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Key facts

Study ID

NCT00849667

Run by

Morphotek

People needed

1100

Starts

2009-04-16

Expected to finish

2013-04-12

Last updated by the study team

2022-12-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
• Must have measurable disease by CT or MRI scan
• Must have relapsed radiologically with a randomization date within ≥6 and < 24 months of completion of first-line platinum chemotherapy
• Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
• Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
• Must be a candidate for carboplatin and taxane therapy
• Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

You may not qualify if…

• Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
• Subjects who have received other therapy to treat their ovarian cancer since relapse
• Known central nervous system (CNS) tumor involvement
• Evidence of other active invasive malignancy requiring treatment in the past 5 years
• Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
• Previous treatment with MORAb-003 (farletuzumab)
• Clinical contraindications to use of a taxane

Where it is running

• Oncology Specialties, PC — Huntsville, Alabama, United States
• Arizona Hematology & Oncology Associates — Phoenix, Arizona, United States
• St. Joseph's Hospital, Barrow Neurology Clinics — Phoenix, Arizona, United States
• Arizona Oncology Associates — Tucson, Arizona, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• Providence St. Joseph Medical Center — Burbank, California, United States
• California Cancer Care, Inc. — Greenbrae, California, United States
• University of California San Diego — La Jolla, California, United States
• University of California Los Angeles Medical Center — Los Angeles, California, United States
• Gynecologic Oncology Associates — Newport Beach, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Catholic Health Initiatives — Colorado Springs, Colorado, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• Hematology Oncology P.C. — Stamford, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Palm Beach Institute of Hematology and Oncology — Boynton Beach, Florida, United States
• University Cancer Institute — Boynton Beach, Florida, United States
• Gainsville Hematology Oncology Associates — Gainesville, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Jupiter Medical center Physician's Group — Jupiter, Florida, United States
• Hematology/Oncology Associates — Lake Worth, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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