Status:
COMPLETED
Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Adenocarcinoma of the Breast
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02204046
Start Date
January 1 2000
Last Update
July 30 2014
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