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

Completed · Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00073541

Run by

EMD Serono

People needed

38

Starts

2003-04-01

Expected to finish

2004-08-01

Last updated by the study team

2017-01-20

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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