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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02204046
First received: July 29, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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


Condition Intervention Phase
Adenocarcinoma
Drug: BIWA 4
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Adenocarcinoma of the Breast

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: up to 6 weeks after infusion ] [ Designated as safety issue: No ]
  • Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 6 weeks after infusion ] [ Designated as safety issue: No ]
  • Number of patients with clinically significant changes in vital signs [ Time Frame: up to 6 weeks after infusion ] [ Designated as safety issue: No ]
  • Presence of Human-Anti-Human-Antibody (HAHA) [ Time Frame: up to 6 weeks after infusion ] [ Designated as safety issue: No ]
  • Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples [ Time Frame: up to 72 hours after infusion ] [ Designated as safety issue: No ]
    Assessment of biodistribution by radioscintigraphy expressed as low, medium or high

  • AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 240 hours after infusion ] [ Designated as safety issue: No ]
  • Cmax (Maximum measured concentration of the analyte in plasma) [ Time Frame: up to 240 hours after infusion ] [ Designated as safety issue: No ]
  • tmax (Time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 240 hours after infusion ] [ Designated as safety issue: No ]
  • t½ (Terminal half-life of the analyte in plasma) [ Time Frame: up to 240 hours after infusion ] [ Designated as safety issue: No ]
  • MRT (Mean residence time of the analyte in the body) [ Time Frame: up to 240 hours after infusion ] [ Designated as safety issue: No ]
  • Vss (Apparent volume of distribution under steady state conditions) [ Time Frame: up to 240 hours after infusion ] [ Designated as safety issue: No ]
  • Vz (Apparent volume of distribution during the terminal phase) [ Time Frame: up to 240 hours after infusion ] [ Designated as safety issue: No ]
  • CL (Total body clearance) [ Time Frame: up to 240 hours after infusion ] [ Designated as safety issue: No ]
  • Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples [ Time Frame: at 72 hours after infusion ] [ Designated as safety issue: No ]
    expressed as %ID/kg

  • Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples [ Time Frame: after surgery on day 8 ] [ Designated as safety issue: No ]
    Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)


Enrollment: 9
Study Start Date: January 2000
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIWA 4

Generic Name: Bivatuzumab

186Re-labelled humanised monoclonal antibody BIWA 4

Drug: BIWA 4

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02204046     History of Changes
Other Study ID Numbers: 1170.2
Study First Received: July 29, 2014
Last Updated: July 29, 2014
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Additional relevant MeSH terms:
Adenocarcinoma
Breast Neoplasms
Breast Diseases
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014