Trial Outcomes & Findings for Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy (NCT NCT00522457)

NCT ID: NCT00522457

Last Updated: 2011-04-29

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

patients are monitored for 6 months

Results posted on

2011-04-29

Participant Flow

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).

Patients were required to complete screening procedures and up to five treatment visits.

Participant milestones

Participant milestones
Measure	Ertumaxomab
Overall Study STARTED	19
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Ertumaxomab
Overall Study Due to disease progression	16
Overall Study Adverse Event	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ertumaxomab n=19 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants

PRIMARY outcome

Timeframe: patients are monitored for 6 months

Population: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: patients are monitored for 6 months

Population: The study was prematurely terminated, therefore no participants were analyzed

The study was prematurely terminated, therefore no participants were analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: patients are monitored for 6 months

Population: The study was prematurely terminated, therefore no participants were analyzed

The study was prematurely terminated, therefore no participants were analyzed

Outcome measures

Outcome data not reported

Adverse Events

Ertumaxomab

Serious events: 11 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ertumaxomab n=19 participants at risk
General disorders pyrexia	21.1% 4/19 • Number of events 4
General disorders asthenia	5.3% 1/19 • Number of events 1
General disorders infusion related reaction	5.3% 1/19 • Number of events 2
Vascular disorders hypotension	21.1% 4/19 • Number of events 6
Vascular disorders hemoptysis	5.3% 1/19 • Number of events 1
Investigations medical observation	15.8% 3/19 • Number of events 11
Gastrointestinal disorders abscess intestinal	5.3% 1/19 • Number of events 1
Gastrointestinal disorders nausea	5.3% 1/19 • Number of events 1
Hepatobiliary disorders bile duct obstruction	5.3% 1/19 • Number of events 1
Hepatobiliary disorders liver abscess	5.3% 1/19 • Number of events 1
Infections and infestations clostridial infection	5.3% 1/19 • Number of events 1
Infections and infestations urinary tract infection	5.3% 1/19 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) malignant neoplasm progression	10.5% 2/19 • Number of events 2
Renal and urinary disorders hydronephrosis	10.5% 2/19 • Number of events 2
Renal and urinary disorders renal failure	5.3% 1/19 • Number of events 1
Renal and urinary disorders ureteric obstruction	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders pleural effusion	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders respiratory acidosis	5.3% 1/19 • Number of events 1
Cardiac disorders supraventricular tachycardia	5.3% 1/19 • Number of events 2
Metabolism and nutrition disorders dehydration	5.3% 1/19 • Number of events 1
Musculoskeletal and connective tissue disorders pain in extremity	5.3% 1/19 • Number of events 1
Nervous system disorders confusional state	5.3% 1/19 • Number of events 1
Psychiatric disorders somnolence	5.3% 1/19 • Number of events 1

Other adverse events

Other adverse events
Measure	Ertumaxomab n=19 participants at risk
General disorders chills	73.7% 14/19 • Number of events 27
General disorders pyrexia	68.4% 13/19 • Number of events 28
General disorders fatigue	57.9% 11/19 • Number of events 15
General disorders pain	15.8% 3/19 • Number of events 3
General disorders chest pain	10.5% 2/19 • Number of events 3
General disorders flank pain	10.5% 2/19 • Number of events 2
General disorders flushing	10.5% 2/19 • Number of events 2
General disorders infusion related reaction	10.5% 2/19 • Number of events 3
General disorders asthenia	5.3% 1/19 • Number of events 1
General disorders lethargy	5.3% 1/19 • Number of events 1
Gastrointestinal disorders nausea	68.4% 13/19 • Number of events 21
Gastrointestinal disorders vomiting	52.6% 10/19 • Number of events 16
Gastrointestinal disorders abdominal pain	15.8% 3/19 • Number of events 5
Gastrointestinal disorders constipation	15.8% 3/19 • Number of events 3
Gastrointestinal disorders diarrhoea	15.8% 3/19 • Number of events 6
Gastrointestinal disorders abdominal discomfort	5.3% 1/19 • Number of events 1
Gastrointestinal disorders abdominal distension	5.3% 1/19 • Number of events 3
Gastrointestinal disorders abscess intestinal	5.3% 1/19 • Number of events 1
Gastrointestinal disorders oral pain	5.3% 1/19 • Number of events 1
Nervous system disorders headaches	73.7% 14/19 • Number of events 20
Nervous system disorders dizziness	10.5% 2/19 • Number of events 2
Nervous system disorders amnesia	5.3% 1/19 • Number of events 1
Nervous system disorders confusional state	5.3% 1/19 • Number of events 1
Nervous system disorders dysgeusia	5.3% 1/19 • Number of events 1
Nervous system disorders neuropathy	5.3% 1/19 • Number of events 1
Nervous system disorders peripheral sensory neuropathy	5.3% 1/19 • Number of events 1
Nervous system disorders photopsia	5.3% 1/19 • Number of events 1
Vascular disorders hypotension	47.4% 9/19 • Number of events 16
Vascular disorders hpertension	21.1% 4/19 • Number of events 6
Vascular disorders hemoptysis	5.3% 1/19 • Number of events 1
Vascular disorders lymphoedema	5.3% 1/19 • Number of events 1
Investigations aspartate aminotransferase increased	21.1% 4/19 • Number of events 5
Investigations alanine aminotransferase increased	15.8% 3/19 • Number of events 4
Investigations c-reactive protein increased	15.8% 3/19 • Number of events 5
Investigations medical observation	15.8% 3/19 • Number of events 11
Investigations blood alkaline phosphatase increased	5.3% 1/19 • Number of events 1
Investigations c-reactive protein	5.3% 1/19 • Number of events 2
Investigations electrocardiogram QT prolonged	5.3% 1/19 • Number of events 1
Investigations gamma-glutamyltransferase increased	5.3% 1/19 • Number of events 1
Investigations weight decreased	5.3% 1/19 • Number of events 1
Musculoskeletal and connective tissue disorders back pain	15.8% 3/19 • Number of events 3
Musculoskeletal and connective tissue disorders pain in extremity	15.8% 3/19 • Number of events 3
Musculoskeletal and connective tissue disorders arthralgia	10.5% 2/19 • Number of events 3
Musculoskeletal and connective tissue disorders myalgia	10.5% 2/19 • Number of events 5
Musculoskeletal and connective tissue disorders muscle spasms	5.3% 1/19 • Number of events 1
Musculoskeletal and connective tissue disorders musculoskeletal stiffness	5.3% 1/19 • Number of events 1
Musculoskeletal and connective tissue disorders pain in jaw	5.3% 1/19 • Number of events 1
Metabolism and nutrition disorders anorexia	26.3% 5/19 • Number of events 7
Metabolism and nutrition disorders hypocalcaemia	10.5% 2/19 • Number of events 2
Metabolism and nutrition disorders decreased appetite	5.3% 1/19 • Number of events 1
Metabolism and nutrition disorders dehydration	5.3% 1/19 • Number of events 1
Metabolism and nutrition disorders hypermagnesemia	5.3% 1/19 • Number of events 2
Metabolism and nutrition disorders hypokalaemia	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders cough	21.1% 4/19 • Number of events 4
Respiratory, thoracic and mediastinal disorders wheezing	15.8% 3/19 • Number of events 3
Respiratory, thoracic and mediastinal disorders dyspnoea	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders dyspnoea exertional	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders pleural effusion	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders respiratory acidosis	5.3% 1/19 • Number of events 1
Blood and lymphatic system disorders lymphopenia	21.1% 4/19 • Number of events 7
Blood and lymphatic system disorders anaemia	15.8% 3/19 • Number of events 3
Blood and lymphatic system disorders leukopenia	10.5% 2/19 • Number of events 2
Blood and lymphatic system disorders neutropenia	10.5% 2/19 • Number of events 2
Cardiac disorders tachycardia	21.1% 4/19 • Number of events 7
Cardiac disorders sinus tachycardia	10.5% 2/19 • Number of events 2
Cardiac disorders supraventricular tachycardia	5.3% 1/19 • Number of events 2
Infections and infestations oral herpes	15.8% 3/19 • Number of events 3
Infections and infestations clostridial infection	5.3% 1/19 • Number of events 1
Infections and infestations localised infection	5.3% 1/19 • Number of events 1
Infections and infestations upper respiratory tract infection	5.3% 1/19 • Number of events 1
Infections and infestations urinary tract infection	5.3% 1/19 • Number of events 1
Psychiatric disorders anxiety	10.5% 2/19 • Number of events 2
Psychiatric disorders insomnia	10.5% 2/19 • Number of events 2
Psychiatric disorders mood altered	5.3% 1/19 • Number of events 1
Psychiatric disorders somnolence	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders erythema	10.5% 2/19 • Number of events 2
Skin and subcutaneous tissue disorders hyperhidrosis	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders ingrowing nail	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders pallor	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders rash	5.3% 1/19 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) malignant neoplasm progression	10.5% 2/19 • Number of events 2
Neoplasms benign, malignant and unspecified (incl cysts and polyps) tumour pain	10.5% 2/19 • Number of events 3
Hepatobiliary disorders bile duct obstruction	5.3% 1/19 • Number of events 1
Hepatobiliary disorders jaundice	5.3% 1/19 • Number of events 1
Hepatobiliary disorders liver abscess	5.3% 1/19 • Number of events 1
Renal and urinary disorders hydronephrosis	10.5% 2/19 • Number of events 2
Renal and urinary disorders renal failure	5.3% 1/19 • Number of events 1
Renal and urinary disorders ureteric obstruction	5.3% 1/19 • Number of events 1
Immune system disorders cytokine release syndrome	5.3% 1/19 • Number of events 1
Reproductive system and breast disorders oedema genital	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders dysphonia	5.3% 1/19 • Number of events 1

Additional Information

Manager of Regulatory Affairs

Fresenius Biotech North America

Phone: 781-699-4652

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER