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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00073541

Enrollment

Registered

2003-11-26

Start date

2003-04-30

Completion date

2004-08-31

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

EGFR; HER-1; monoclonal antibody; targeted therapy

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 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.

Interventions

DRUGEMD 72000

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026