Clinical trial · Interventional
Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Adenocarcinoma of the Breast
A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Adenocarcinoma of the Breast
NCT02204046CI-TRIAL-00015255completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIWA 4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BIWA 4
- description
- Generic Name: Bivatuzumab 186Re-labelled humanised monoclonal antibody BIWA 4
- interventionNames
- Drug: BIWA 4
Primary outcomes (15)
- measure
- Number of patients with adverse events
- timeFrame
- up to 6 weeks after infusion
- measure
- Number of patients with abnormal changes in laboratory parameters
- timeFrame
- up to 6 weeks after infusion
- measure
- Number of patients with clinically significant changes in vital signs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.