Clinical trial NCT02204046: Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Adenocarcinoma of the Breast
Official title: A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Adenocarcinoma of the Breast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenocarcinoma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
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: up to 6 weeks after infusion
measure: Presence of Human-Anti-Human-Antibody (HAHA)
timeFrame: up to 6 weeks after infusion
measure: Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
timeFrame: up to 72 hours after infusion
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 240 hours after infusion
measure: Cmax (Maximum measured concentration of the analyte in plasma)
timeFrame: up to 240 hours after infusion
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: up to 240 hours after infusion
measure: t½ (Terminal half-life of the analyte in plasma)
timeFrame: up to 240 hours after infusion
measure: MRT (Mean residence time of the analyte in the body)
timeFrame: up to 240 hours after infusion
measure: Vss (Apparent volume of distribution under steady state conditions)
timeFrame: up to 240 hours after infusion
measure: Vz (Apparent volume of distribution during the terminal phase)
timeFrame: up to 240 hours after infusion
measure: CL (Total body clearance)
timeFrame: up to 240 hours after infusion
measure: Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
timeFrame: at 72 hours after infusion
measure: Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
timeFrame: after surgery on day 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: