Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Adenocarcinoma of the Breast
- Registration Number
- NCT02204046
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objectives of this study were to assess the safety and tolerability of intravenously (i.v.) administered 186Rhenium (186Re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186Re-labelled bivatuzumab in patients with adenocarcinoma of the breast
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Patients must have histological or cytological confirmation of a primary adenocarcinoma of the breast
- Patients destined for tumour extirpation or mastectomy
- 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
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Life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on 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
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White blood cell count < 3000/mm³, granulocyte count < 1500/mm³ or platelet count < 100000/mm³. Details of prior chemotherapy or radiotherapy had to be known
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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 BIWA 4 BIWA 4 Generic Name: Bivatuzumab 186Re-labelled humanised monoclonal antibody BIWA 4
- Primary Outcome Measures
Name Time Method t½ (Terminal half-life of the analyte in plasma) up to 240 hours after infusion Number of patients with adverse events up to 6 weeks after infusion Vss (Apparent volume of distribution under steady state conditions) up to 240 hours after infusion Number of patients with clinically significant changes in vital signs up to 6 weeks after infusion 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)
Vz (Apparent volume of distribution during the terminal phase) up to 240 hours after infusion AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 240 hours after infusion Presence of Human-Anti-Human-Antibody (HAHA) up to 6 weeks after infusion Cmax (Maximum measured concentration of the analyte in plasma) up to 240 hours after infusion MRT (Mean residence time of the analyte in the body) up to 240 hours after infusion CL (Total body clearance) up to 240 hours after infusion tmax (Time from dosing to the maximum concentration of the analyte in plasma) up to 240 hours after infusion Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples at 72 hours after infusion expressed as %ID/kg
Number of patients with abnormal changes in laboratory parameters up to 6 weeks after infusion
- Secondary Outcome Measures
Name Time Method