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

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

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma
• Intervention / Treatment: Drug: BIWA 4

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIWA 4; Generic Name: Bivatuzumab 186Re-labelled humanised monoclonal antibody BIWA 4	Drug: BIWA 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with clinically significant changes in vital signs		up to 6 weeks after infusion
Number of patients with abnormal changes in laboratory parameters		up to 6 weeks after infusion
Number of patients with adverse events		up to 6 weeks after infusion
Presence of Human-Anti-Human-Antibody (HAHA)		up to 6 weeks after infusion
Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples	Assessment of biodistribution by radioscintigraphy expressed as low, medium or high	up to 72 hours after infusion
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)		up to 240 hours after infusion
Cmax (Maximum measured concentration of the analyte in plasma)		up to 240 hours after infusion
tmax (Time from dosing to the maximum concentration of the analyte in plasma)		up to 240 hours after infusion
t½ (Terminal half-life of the analyte in plasma)		up to 240 hours after infusion
MRT (Mean residence time of the analyte in the body)		up to 240 hours after infusion
Vss (Apparent volume of distribution under steady state conditions)		up to 240 hours after infusion
Vz (Apparent volume of distribution during the terminal phase)		up to 240 hours after infusion
CL (Total body clearance)		up to 240 hours after infusion
Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples	expressed as %ID/kg	at 72 hours after infusion
Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples	Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)	after surgery on day 8

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): February 1, 2001

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 1170.2