A Phase 1 interventional study of hMAb BIWA 4 in Carcinoma, Non-Small-Cell Lung, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-30.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
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)
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 9 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pre-menopausal women (last menstruation \<= 1 year prior to study start)
Bivatuzumab: 186 Re-labelled humanised monoclonal antibody BIWA 4
Drug: hMAb BIWA 4
Number of patients with adverse events
Time frame: up to 6 weeks post infusion
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 6 weeks post infusion
Number of patients with clinically significant changes in vital signs
Time frame: up to 6 weeks post infusion
Presence of Human-Anti-Human-Antibody (HAHA)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: up to 6 weeks post infusion
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 6 weeks post infusion
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 6 weeks post infusion
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 6 weeks post infusion
MRT (Mean residence time of the analyte in the body)
Time frame: up to 6 weeks post infusion
Vss (Apparent volume of distribution under steady state conditions)
Time frame: up to 6 weeks post infusion
Vz (Apparent volume of distribution during the terminal phase)
Time frame: up to 6 weeks post infusion
CL (Total body clearance)
Time frame: up to 6 weeks post infusion
No study locations are listed for this record.
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Boehringer Ingelheim