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Completed

NCT Number: NCT02204046

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIWA 4

Drug

Primary outcomes

  1. Number of patients with adverse events

    Time frame: up to 6 weeks after infusion

  2. Number of patients with abnormal changes in laboratory parameters

    Time frame: up to 6 weeks after infusion

  3. Number of patients with clinically significant changes in vital signs

    Time frame: up to 6 weeks after infusion

  4. Presence of Human-Anti-Human-Antibody (HAHA)

    Time frame: up to 6 weeks after infusion

  5. Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples

    Time frame: up to 72 hours after infusion

    Assessment of biodistribution by radioscintigraphy expressed as low, medium or high

  6. 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

  7. Cmax (Maximum measured concentration of the analyte in plasma)

    Time frame: up to 240 hours after infusion

  8. tmax (Time from dosing to the maximum concentration of the analyte in plasma)

    Time frame: up to 240 hours after infusion

  9. t½ (Terminal half-life of the analyte in plasma)

    Time frame: up to 240 hours after infusion

  10. MRT (Mean residence time of the analyte in the body)

    Time frame: up to 240 hours after infusion

  11. Vss (Apparent volume of distribution under steady state conditions)

    Time frame: up to 240 hours after infusion

  12. Vz (Apparent volume of distribution during the terminal phase)

    Time frame: up to 240 hours after infusion

  13. CL (Total body clearance)

    Time frame: up to 240 hours after infusion

  14. Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples

    Time frame: at 72 hours after infusion

    expressed as %ID/kg

  15. Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples

    Time frame: after surgery on day 8

    Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2001
First posted
Jul 30, 2014
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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