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The primary objectives of this study is to assess the safety and tolerability of intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in patients with non-small cell lung cancer (NSCLC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hMAb BIWA 4 | Experimental | Bivatuzumab: 186 Re-labelled humanised monoclonal antibody BIWA 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hMAb BIWA 4 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to 6 weeks post infusion | |
| Number of patients with abnormal changes in laboratory parameters | up to 6 weeks post infusion | |
| Number of patients with clinically significant changes in vital signs | up to 6 weeks post infusion | |
| Presence of Human-Anti-Human-Antibody (HAHA) | up to 6 weeks post infusion | |
| Biodistribution of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples | assessed by radioimmunoscintigraphy expressed as no, low, medium or high | up to 96 hours post infusion |
| Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples | Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg) | after surgery on day 8 |
| AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 6 weeks post infusion | |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 6 weeks post infusion | |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) |
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Inclusion Criteria:
Exclusion Criteria:
Life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on Electrocardiogram (ECG) or unstable angina pectoris
Pre-menopausal women (last menstruation <= 1 year prior to study start)
Women with a positive serum pregnancy test at baseline
White blood cell count < 3000/mm³, granulocyte count < 1500/mm³ or platelet count < 100000/mm³. Details of prior chemotherapy and radiotherapy had to be known.
Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| up to 6 weeks post infusion |
| t½ (Terminal half-life of the analyte in plasma) | up to 6 weeks post infusion |
| MRT (Mean residence time of the analyte in the body) | up to 6 weeks post infusion |
| Vss (Apparent volume of distribution under steady state conditions) | up to 6 weeks post infusion |
| Vz (Apparent volume of distribution during the terminal phase) | up to 6 weeks post infusion |
| CL (Total body clearance) | up to 6 weeks post infusion |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |