Rich66
12-30-2008, 01:44 PM
http://clinicaltrials.gov/ct2/show/NCT00522457?spons=%22Fresenius+Biotech+North+Ameri ca%22&spons_ex=Y&rank=2
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
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
http://clinicaltrials.gov/ct2/html/images/frame/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.
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 (http://clinicaltrials.gov/ct2/help/conditions_desc) Intervention (http://clinicaltrials.gov/ct2/help/interventions_desc) Phase (http://clinicaltrials.gov/ct2/help/phase_desc) Metastatic Breast Cancer
Advanced Breast Cancer
Drug: ertumaxomab
Phase II
Genetics Home Reference (http://ghr.nlm.nih.gov/) related topics: breast cancer (http://clinicaltrials.gov/ct2/bye/mQoPWw4lZXcilwpxudhWudNzlXNiZip90dcx5Q1PedcO9BUyzB 1gWBcGuBcHS.)
MedlinePlus (http://www.nlm.nih.gov/medlineplus/) related topics: Breast Cancer (http://clinicaltrials.gov/ct2/bye/WQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS9pwNHkw-P0B7x061nuQoPmdt.) Cancer (http://clinicaltrials.gov/ct2/bye/uQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS90B7x061nuQoPmdt .)
Drug Information (http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp) available for: Immunoglobulins (http://clinicaltrials.gov/ct2/bye/nQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789D7Lmi7xZ6caZBUHvQ7xF.) Globulin, Immune (http://clinicaltrials.gov/ct2/bye/XQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789PcaZBUHvQ7OzR5RfD7Lmi7xz.) Visilizumab (http://clinicaltrials.gov/ct2/bye/jQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789HNzFQ7aeTUHmB7n.) Trastuzumab (http://clinicaltrials.gov/ct2/bye/jQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789Hoykw-PLTUHmB7n.) Ertumaxomab (http://clinicaltrials.gov/ct2/bye/jQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789P1yWi7LkTh9mB7n.)
U.S. FDA Resources (http://clinicaltrials.gov/ct2/info/fdalinks)
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:
Clinical efficacy measured by objective response rate (best response during the course of the study)
Secondary Outcome Measures:
Duration of response
Clinical benefit rate
Safety
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/images/frame/triangle.gif Eligibility Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Criteria
Key Inclusion Criteria:
Women ≥ 18 years, Negative pregnancy test at screening and life expectancy of at least 3 months
metastatic (stage IV) and not curable adenocarcinoma of the breast
Measurable disease, defined as at least one lesion that is measurable in one dimension (RECIST)
HER-2 overexpression 3+ or 2+ FISH positive
Patients must have received one prior therapy with trastuzumab as last treatment before entry into the study. If trastuzumab was given as single agent treatment, patients must have received prior chemotherapy for metastatic disease
Trastuzumab has been discontinued before study entry
disease had progressed during or after trastuzumab therapy
ECOG performance score of ≤ 2
Adequate hematological, liver and kidney function
Key Exclusion Criteria:
Women who are pregnant or breast feeding
Any history or symptoms indicative of brain or central nervous system metastases
Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Human anti-murine antibody positive or hypersensitivity to murine proteins and any other component of the study drug
Known autoimmune diseases, HIV, hepatitis B or C infection as well as other acute or chronic infection or other concurrent non-malignant co-morbidities that are uncontrolled
Any concurrent chemotherapy, hormonal therapy, immunotherapy or corticoid therapy
Concurrent antibiotic treatment
Any concurrent investigational treatment for metastatic disease
Cardiovascular exclusion criteria:
Unstable or uncontrolled pectorial angina
Myocardial infarction during the last 6 months
Valvular heart disease that requires treatment
Cardiomyopathy (congestive, hypertrophic or restrictive)
Acute myocarditis
Congestive heart failure (CHF): dyspnea, clinically or radiologically diagnosed
Left ventricular ejection fraction (LVEF)outside institution's normal range based on echocardiography at rest
Left ventricular diameter > 56 mm based on M-mode echocardiography at rest
Arrhythmias that require treatment (atrioventricular block II/III degree, atrial fibrillation, ventricular tachycardia)
Poorly or uncontrolled hypertension, asthma, seizures, allergies, pulmonary dysfunction
http://clinicaltrials.gov/ct2/html/images/frame/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
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
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
http://clinicaltrials.gov/ct2/html/images/frame/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.
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 (http://clinicaltrials.gov/ct2/help/conditions_desc) Intervention (http://clinicaltrials.gov/ct2/help/interventions_desc) Phase (http://clinicaltrials.gov/ct2/help/phase_desc) Metastatic Breast Cancer
Advanced Breast Cancer
Drug: ertumaxomab
Phase II
Genetics Home Reference (http://ghr.nlm.nih.gov/) related topics: breast cancer (http://clinicaltrials.gov/ct2/bye/mQoPWw4lZXcilwpxudhWudNzlXNiZip90dcx5Q1PedcO9BUyzB 1gWBcGuBcHS.)
MedlinePlus (http://www.nlm.nih.gov/medlineplus/) related topics: Breast Cancer (http://clinicaltrials.gov/ct2/bye/WQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS9pwNHkw-P0B7x061nuQoPmdt.) Cancer (http://clinicaltrials.gov/ct2/bye/uQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS90B7x061nuQoPmdt .)
Drug Information (http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp) available for: Immunoglobulins (http://clinicaltrials.gov/ct2/bye/nQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789D7Lmi7xZ6caZBUHvQ7xF.) Globulin, Immune (http://clinicaltrials.gov/ct2/bye/XQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789PcaZBUHvQ7OzR5RfD7Lmi7xz.) Visilizumab (http://clinicaltrials.gov/ct2/bye/jQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789HNzFQ7aeTUHmB7n.) Trastuzumab (http://clinicaltrials.gov/ct2/bye/jQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789Hoykw-PLTUHmB7n.) Ertumaxomab (http://clinicaltrials.gov/ct2/bye/jQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789P1yWi7LkTh9mB7n.)
U.S. FDA Resources (http://clinicaltrials.gov/ct2/info/fdalinks)
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:
Clinical efficacy measured by objective response rate (best response during the course of the study)
Secondary Outcome Measures:
Duration of response
Clinical benefit rate
Safety
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/images/frame/triangle.gif Eligibility Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Criteria
Key Inclusion Criteria:
Women ≥ 18 years, Negative pregnancy test at screening and life expectancy of at least 3 months
metastatic (stage IV) and not curable adenocarcinoma of the breast
Measurable disease, defined as at least one lesion that is measurable in one dimension (RECIST)
HER-2 overexpression 3+ or 2+ FISH positive
Patients must have received one prior therapy with trastuzumab as last treatment before entry into the study. If trastuzumab was given as single agent treatment, patients must have received prior chemotherapy for metastatic disease
Trastuzumab has been discontinued before study entry
disease had progressed during or after trastuzumab therapy
ECOG performance score of ≤ 2
Adequate hematological, liver and kidney function
Key Exclusion Criteria:
Women who are pregnant or breast feeding
Any history or symptoms indicative of brain or central nervous system metastases
Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Human anti-murine antibody positive or hypersensitivity to murine proteins and any other component of the study drug
Known autoimmune diseases, HIV, hepatitis B or C infection as well as other acute or chronic infection or other concurrent non-malignant co-morbidities that are uncontrolled
Any concurrent chemotherapy, hormonal therapy, immunotherapy or corticoid therapy
Concurrent antibiotic treatment
Any concurrent investigational treatment for metastatic disease
Cardiovascular exclusion criteria:
Unstable or uncontrolled pectorial angina
Myocardial infarction during the last 6 months
Valvular heart disease that requires treatment
Cardiomyopathy (congestive, hypertrophic or restrictive)
Acute myocarditis
Congestive heart failure (CHF): dyspnea, clinically or radiologically diagnosed
Left ventricular ejection fraction (LVEF)outside institution's normal range based on echocardiography at rest
Left ventricular diameter > 56 mm based on M-mode echocardiography at rest
Arrhythmias that require treatment (atrioventricular block II/III degree, atrial fibrillation, ventricular tachycardia)
Poorly or uncontrolled hypertension, asthma, seizures, allergies, pulmonary dysfunction
http://clinicaltrials.gov/ct2/html/images/frame/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