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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

EMD 72000-030

NCT ID:

NCT00073541

Start Date:

September 2003

Completion Date:

August 2004

Related Keywords:

  • Ovarian Cancer
  • EGFR; HER-1; monoclonal antibody; targeted therapy
  • Ovarian Neoplasms

Name

Location

Albany, New York  12208
Nashville, Tennessee  37203-1632
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina