Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer
Completed · Phase 1
Conditions studied: Epithelial Ovarian Cancer
In brief
The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.
Key facts
- Study ID
- NCT01004380
- Run by
- Morphotek
- People needed
- 15
- Starts
- 2009-11-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2014-07-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of epithelial ovarian cancer
- Must have measurable disease by CT or MRI scan
- Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy
- Must have been treated with surgery and be a candidate for repeat carboplatin therapy
- Must have a normal cardiac ejection fraction at baseline
You may not qualify if…
- Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs <6 months from the last platinum therapy
- Subjects who have received other therapy to treat their ovarian cancer since last relapse
- Known central nervous system tumor involvement
- Evidence of other active invasive malignancy
- Clinically significant heart disease
- Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
- Previous treatment with MORAb 003 (farletuzumab)
- Previous treatment with anthracyclines
- Clinical contraindications to use PLD
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.