Adenocarcinoma
Conditions
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
Interventions
DRUGBIWA 4
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
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 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 or radiotherapy had to be known * Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | up to 6 weeks after infusion | — |
| Number of patients with abnormal changes in laboratory parameters | up to 6 weeks after infusion | — |
| Number of patients with clinically significant changes in vital signs | up to 6 weeks after infusion | — |
| Presence of Human-Anti-Human-Antibody (HAHA) | up to 6 weeks after infusion | — |
| Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples | up to 72 hours after infusion | Assessment of biodistribution by radioscintigraphy expressed as low, medium or high |
| 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 | — |
| Cmax (Maximum measured concentration of the analyte in plasma) | 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 | — |
| t½ (Terminal half-life 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 | — |
| Vss (Apparent volume of distribution under steady state conditions) | up to 240 hours after infusion | — |
| Vz (Apparent volume of distribution during the terminal phase) | up to 240 hours after infusion | — |
| CL (Total body clearance) | 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 |
Outcome results
None listed