Completed
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
What is being tested
Data Collection
Who is being recruted
Urogenital Diseases+12
+ Genital Diseases
+ Adnexal Diseases
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: April 2003
Summary
Principal SponsorEMD Serono
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2003
Actual date on which the first participant was enrolled.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.
Official TitleAn 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
Principal SponsorEMD Serono
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
38 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases
Criteria
5 inclusion criteria required to participate
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
Show More Criteria
10 exclusion criteria prevent from participating
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)
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers