A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer

An Open-Label Phase II Study in Subjects With Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent

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 receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.

Inclusion Criteria:

• 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 Criteria:

• 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