Completed

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

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What is being tested

EMD 72000

Drug
Who is being recruted

Ovarian Cancer

Over 18 Years
+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2003

See protocol details

Summary

Principal SponsorEMD Serono
Last updated: January 20, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2003Actual 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 20, 2017
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 enrolledTotal 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.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Ovarian Cancer
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

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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)

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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 5 locations
Suspended
Unknown FacilityBaltimore, United StatesSee the location
Suspended
Unknown FacilityBoston, United States
Suspended
Unknown FacilityNew York, United States
Suspended
Unknown FacilityCharlotte, United States
Completed5 Study Centers