HonCode

Go Back   HER2 Support Group Forums > Clinical Trials
Register Gallery FAQ Members List Calendar Search Today's Posts Mark Forums Read

Reply
 
Thread Tools Display Modes
Old 12-30-2008, 01:44 PM   #1
Rich66
Senior Member
 
Rich66's Avatar
 
Join Date: Feb 2008
Location: South East Wisconsin
Posts: 3,431
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
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
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 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:
  • 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 g (day 0); 100 g (day 7 1 day) and 100 g (day 14 1 day) (flat doses).




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



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
__________________

Mom's treatment history (link)
Rich66 is offline   Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -7. The time now is 11:14 PM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2018, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007
free webpage hit counter