Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast
http://clinicaltrials.gov/ct2/show/N...ns_ex=Y&rank=2
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy http://clinicaltrials.gov/ct2/html/i...e/triangle.gif Purpose This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with HER 2/neu overexpressing (3+ or 2+ with a positive FISH test result) metastatic breast cancer progressing after trastuzumab treatment.This study is currently recruiting participants. Verified by Fresenius Biotech GmbH, March 2008 Sponsors and Collaborators: Fresenius Biotech GmbH Fresenius Biotech North America Information provided by: Fresenius Biotech GmbH ClinicalTrials.gov Identifier: NCT00522457 Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory immune effector cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response. Condition Intervention Phase Metastatic Breast Cancer Advanced Breast Cancer Drug: ertumaxomab Phase II Genetics Home Reference related topics: breast cancer MedlinePlus related topics: Breast Cancer Cancer Drug Information available for: Immunoglobulins Globulin, Immune Visilizumab Trastuzumab Ertumaxomab U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study Official Title: Phase II Study Of The Trifunctional Bispecific Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab In Patients With HER-2/Neu Overexpressing (3+ Or 2+/FISH+) Metastatic Breast Cancer Progressing After Trastuzumab Treatment Further study details as provided by Fresenius Biotech GmbH: Primary Outcome Measures:
Secondary Outcome Measures:
Estimated Enrollment: 40 Study Start Date: August 2007 Detailed Description: This study is an open-label, non-randomized, uncontrolled, two-stage phase II study evaluating the efficacy and safety of ertumaxomab. Ertumaxomab will be administered three times at 7 day intervals by constant rate 3 hour intravenous (i.v.) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7 ± 1 day) and 100 µg (day 14 ± 1 day) (flat doses). http://clinicaltrials.gov/ct2/html/i...e/triangle.gif Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Key Inclusion Criteria:
http://clinicaltrials.gov/ct2/html/i...e/triangle.gif Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00522457 Contacts Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com Locations United States, Minnesota Recruiting Minneapolis, Minnesota, United States Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com United States, New Hampshire Recruiting Lebanon, New Hampshire, United States Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com United States, New York Recruiting New York, New York, United States Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com United States, South Carolina Recruiting Spartanburg, South Carolina, United States Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com Canada, Ontario Recruiting Ottawa, Ontario, Canada Contact: Barbara Kolb 1-866-580-7270 clinicaltrials@fresenius-biotech.com Sponsors and Collaborators Fresenius Biotech GmbH Fresenius Biotech North America Investigators Principal Investigator: Gary Schwartz, MD Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center; Lebanon, NH |
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