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Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy

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ClinicalTrials.gov Identifier: NCT00522457
Recruitment Status : Terminated (change in development plan, not due to safety concerns.)
First Posted : August 29, 2007
Results First Posted : April 29, 2011
Last Update Posted : April 29, 2011
Sponsor:
Collaborator:
Fresenius Biotech North America
Information provided by:
Neovii Biotech

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Breast Cancer
Advanced Breast Cancer
Intervention Drug: ertumaxomab
Enrollment 19
Recruitment Details Open-label phase 2 study evaluating the efficacy and safety of ertumaxomab for the treatment of metastatic breast cancer tumors. Ertumaxomab will be administered 3 times at 7 day intervals by constant rate 3 hour intravenous (IV) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7±1)and 100 µg(day14±1)(flat doses).
Pre-assignment Details Patients were required to complete screening procedures and up to five treatment visits.
Arm/Group Title Ertumaxomab
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 19
Completed 1
Not Completed 18
Reason Not Completed
Due to disease progression             16
Adverse Event             2
Arm/Group Title Ertumaxomab
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
19
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
United States 12
Canada 7
1.Primary Outcome
Title Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)
Hide Description [Not Specified]
Time Frame patients are monitored for 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was prematurely terminated, therefore no participants were analyzed. The primary endpoint was the objective response rate (ORR) to ertumaxomab (best response during the course of the study), defined as the number of patients with CR or PR according to RECIST, relative to the total population of treated patients
Arm/Group Title Ertumaxomab
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Duration of Response
Hide Description The study was prematurely terminated, therefore no participants were analyzed
Time Frame patients are monitored for 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was prematurely terminated, therefore no participants were analyzed
Arm/Group Title Ertumaxomab
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Clinical Benefit Rate
Hide Description The study was prematurely terminated, therefore no participants were analyzed
Time Frame patients are monitored for 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was prematurely terminated, therefore no participants were analyzed
Arm/Group Title Ertumaxomab
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ertumaxomab
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Ertumaxomab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ertumaxomab
Affected / at Risk (%) # Events
Total   11/19 (57.89%)    
Cardiac disorders   
supraventricular tachycardia  1/19 (5.26%)  2
Gastrointestinal disorders   
abscess intestinal  1/19 (5.26%)  1
nausea  1/19 (5.26%)  1
General disorders   
pyrexia  4/19 (21.05%)  4
asthenia  1/19 (5.26%)  1
infusion related reaction  1/19 (5.26%)  2
Hepatobiliary disorders   
bile duct obstruction  1/19 (5.26%)  1
liver abscess  1/19 (5.26%)  1
Infections and infestations   
clostridial infection  1/19 (5.26%)  1
urinary tract infection  1/19 (5.26%)  1
Investigations   
medical observation  3/19 (15.79%)  11
Metabolism and nutrition disorders   
dehydration  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
pain in extremity  1/19 (5.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
malignant neoplasm progression  2/19 (10.53%)  2
Nervous system disorders   
confusional state  1/19 (5.26%)  1
Psychiatric disorders   
somnolence  1/19 (5.26%)  1
Renal and urinary disorders   
hydronephrosis  2/19 (10.53%)  2
renal failure  1/19 (5.26%)  1
ureteric obstruction  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
pleural effusion  1/19 (5.26%)  1
respiratory acidosis  1/19 (5.26%)  1
Vascular disorders   
hypotension  4/19 (21.05%)  6
hemoptysis  1/19 (5.26%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ertumaxomab
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
lymphopenia  4/19 (21.05%)  7
anaemia  3/19 (15.79%)  3
leukopenia  2/19 (10.53%)  2
neutropenia  2/19 (10.53%)  2
Cardiac disorders   
tachycardia  4/19 (21.05%)  7
sinus tachycardia  2/19 (10.53%)  2
supraventricular tachycardia  1/19 (5.26%)  2
Gastrointestinal disorders   
nausea  13/19 (68.42%)  21
vomiting  10/19 (52.63%)  16
abdominal pain  3/19 (15.79%)  5
constipation  3/19 (15.79%)  3
diarrhoea  3/19 (15.79%)  6
abdominal discomfort  1/19 (5.26%)  1
abdominal distension  1/19 (5.26%)  3
abscess intestinal  1/19 (5.26%)  1
oral pain  1/19 (5.26%)  1
General disorders   
chills  14/19 (73.68%)  27
pyrexia  13/19 (68.42%)  28
fatigue  11/19 (57.89%)  15
pain  3/19 (15.79%)  3
chest pain  2/19 (10.53%)  3
flank pain  2/19 (10.53%)  2
flushing  2/19 (10.53%)  2
infusion related reaction  2/19 (10.53%)  3
asthenia  1/19 (5.26%)  1
lethargy  1/19 (5.26%)  1
Hepatobiliary disorders   
bile duct obstruction  1/19 (5.26%)  1
jaundice  1/19 (5.26%)  1
liver abscess  1/19 (5.26%)  1
Immune system disorders   
cytokine release syndrome  1/19 (5.26%)  1
Infections and infestations   
oral herpes  3/19 (15.79%)  3
clostridial infection  1/19 (5.26%)  1
localised infection  1/19 (5.26%)  1
upper respiratory tract infection  1/19 (5.26%)  1
urinary tract infection  1/19 (5.26%)  1
Investigations   
aspartate aminotransferase increased  4/19 (21.05%)  5
alanine aminotransferase increased  3/19 (15.79%)  4
c-reactive protein increased  3/19 (15.79%)  5
medical observation  3/19 (15.79%)  11
blood alkaline phosphatase increased  1/19 (5.26%)  1
c-reactive protein  1/19 (5.26%)  2
electrocardiogram QT prolonged  1/19 (5.26%)  1
gamma-glutamyltransferase increased  1/19 (5.26%)  1
weight decreased  1/19 (5.26%)  1
Metabolism and nutrition disorders   
anorexia  5/19 (26.32%)  7
hypocalcaemia  2/19 (10.53%)  2
decreased appetite  1/19 (5.26%)  1
dehydration  1/19 (5.26%)  1
hypermagnesemia  1/19 (5.26%)  2
hypokalaemia  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
back pain  3/19 (15.79%)  3
pain in extremity  3/19 (15.79%)  3
arthralgia  2/19 (10.53%)  3
myalgia  2/19 (10.53%)  5
muscle spasms  1/19 (5.26%)  1
musculoskeletal stiffness  1/19 (5.26%)  1
pain in jaw  1/19 (5.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
malignant neoplasm progression  2/19 (10.53%)  2
tumour pain  2/19 (10.53%)  3
Nervous system disorders   
headaches  14/19 (73.68%)  20
dizziness  2/19 (10.53%)  2
amnesia  1/19 (5.26%)  1
confusional state  1/19 (5.26%)  1
dysgeusia  1/19 (5.26%)  1
neuropathy  1/19 (5.26%)  1
peripheral sensory neuropathy  1/19 (5.26%)  1
photopsia  1/19 (5.26%)  1
Psychiatric disorders   
anxiety  2/19 (10.53%)  2
insomnia  2/19 (10.53%)  2
mood altered  1/19 (5.26%)  1
somnolence  1/19 (5.26%)  1
Renal and urinary disorders   
hydronephrosis  2/19 (10.53%)  2
renal failure  1/19 (5.26%)  1
ureteric obstruction  1/19 (5.26%)  1
Reproductive system and breast disorders   
oedema genital  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
cough  4/19 (21.05%)  4
wheezing  3/19 (15.79%)  3
dyspnoea  1/19 (5.26%)  1
dyspnoea exertional  1/19 (5.26%)  1
pleural effusion  1/19 (5.26%)  1
respiratory acidosis  1/19 (5.26%)  1
dysphonia  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
erythema  2/19 (10.53%)  2
hyperhidrosis  1/19 (5.26%)  1
ingrowing nail  1/19 (5.26%)  1
pallor  1/19 (5.26%)  1
rash  1/19 (5.26%)  1
Vascular disorders   
hypotension  9/19 (47.37%)  16
hpertension  4/19 (21.05%)  6
hemoptysis  1/19 (5.26%)  1
lymphoedema  1/19 (5.26%)  1
The study was prematurely terminated. This decision was based on strategic changes in the company's research and development program and resulted in limited patient data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Site may publish the results of the Study after such cooperative publication, or 1 year after Sponsor's final evaluation of all the Study data from all sites, whichever occurs first. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Fresenius Biotech at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manager of Regulatory Affairs
Organization: Fresenius Biotech North America
Phone: 781-699-4652
EMail: bao.le@fresenius-biotech.com
Layout table for additonal information
Responsible Party: Manager of Regulatory Affairs, Fresenius Biotech North America
ClinicalTrials.gov Identifier: NCT00522457     History of Changes
Other Study ID Numbers: IV-ERT-BC-04
First Submitted: August 28, 2007
First Posted: August 29, 2007
Results First Submitted: March 1, 2011
Results First Posted: April 29, 2011
Last Update Posted: April 29, 2011