Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Adenocarcinoma of the Breast

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

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