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

NCT02204046 | Completed Phase 1

• 1 other identifier: 1170.2
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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

Conditions

Adenocarcinoma

Outcome Measures

Primary Outcomes (15)

• Number of patients with adverse events

  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 clinically significant changes in vital signs

  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

Study Arms (1)

BIWA 4

EXPERIMENTAL

Generic Name: Bivatuzumab 186Re-labelled humanised monoclonal antibody BIWA 4

Drug: BIWA 4

Interventions

BIWA 4 DRUG

BIWA 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Adenocarcinoma

Interventions

monoclonal antibody BIWA 4

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 30, 2014
• Study Start: January 1, 2000
• Primary Completion: February 1, 2001
• Last Updated: July 30, 2014

Record last verified: 2014-07