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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Adenocarcinoma

Treatments

Drug: BIWA 4

Study type

Interventional

Funder types

Industry

Identifiers

NCT02204046

1170.2

Details and patient eligibility

About

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

Enrollment

9 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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