Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Non-small Cell Lung Cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Drug: hMAb BIWA 4
- Registration Number
- NCT02204059
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Patients must have histological or cytological confirmation of Non small cell lung cancer (NSCLC) stage I, II or IIIa according to the staging system of the American Joint Committee on Cancer (AJCC)
- Patients destined for resection of the tumour
- Patients over 18 years of age
- Patients younger than 80 years of age
- Patients who had given 'written informed consent'
- Patients with a life expectancy of at least 3 months
- Patients with a good performance status: Karnofsky > 60
-
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)
- Not surgically sterile (hysterectomy, tubal ligation) and
- Not practicing acceptable means of birth control, (or not planned to be continued throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description hMAb BIWA 4 hMAb BIWA 4 Bivatuzumab: 186 Re-labelled humanised monoclonal antibody BIWA 4
- Primary Outcome Measures
Name Time Method 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 up to 96 hours post infusion assessed by radioimmunoscintigraphy expressed as no, low, medium or high
Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples after surgery on day 8 Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)
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) up to 6 weeks post infusion Number of patients with adverse events 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 t½ (Terminal half-life of the analyte in plasma) up to 6 weeks post infusion
- Secondary Outcome Measures
Name Time Method