Status:
COMPLETED
A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer
Lead Sponsor:
EMD Serono
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor recept...
Eligibility Criteria
Inclusion
- Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease
- Immunohistochemical evidence of tumor EGFR (HER-1) expression
- At least one measurable lesion according to the WHO criteria
- Life expectancy ≥ 12 weeks
- ECOG performance status 0-1
Exclusion
- History of prior MAb therapy
- History of prior treatment with an EGFR (HER-1) directed therapy
- Known brain metastases
- Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted)
- Known intercurrent infections or immunosuppression
- Actively infected with, or chronic carriers of HBV
- Evidence of HCV disease
- Previous diagnosis of autoimmune disease
- Known hypersensitivity to the administered drugs or any of their components
- Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00073541
Start Date
April 1 2003
End Date
August 1 2004
Last Update
January 20 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Baltimore, Maryland, United States
2
Boston, Massachusetts, United States
3
New York, New York, United States
4
Charlotte, North Carolina, United States