Status:
TERMINATED
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Lead Sponsor:
Morphotek
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-99 years
Phase:
PHASE2
Brief Summary
The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003 (farletuzumab) or alone in patients with platinum-resistant or refrac...
Detailed Description
Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (ser...
Eligibility Criteria
Inclusion
- Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks prior to study entry
- Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically within 6 months of most recent platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.
- Must have been treated with debulking surgery and at least one line platinum-based chemotherapy;
- Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance.
- Subjects must be candidate for repeat paclitaxel treatment
Exclusion
- Clinical contraindications to use of paclitaxel, which include:
- persistent Grade 2 or greater peripheral neuropathy
- prior hypersensitivity reaction that persisted despite rechallenge with or without desensitization or resulted in bronchospasm or hemodynamic instability or was at least Grade 2 and resulted in medication discontinuation
- Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that has been surgically resected is acceptable provided the subject did
- Prior radiation therapy is excluded with the exception that it is allowable only if measurable disease for ovarian cancer is completely outside the radiation portal
- Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA).
- Previous treatment with MORAb-003 (farletuzumab).
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT00738699
Start Date
September 1 2008
End Date
January 1 2012
Last Update
March 30 2017
Active Locations (61)
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1
Southern Cancer Center
Mobile, Alabama, United States, 36608
2
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
3
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
4
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093