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

Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204046
• Other study ID #: 1170.2
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2014
• Last updated: July 29, 2014
• Start date: January 2000

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. primary completion date: February 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Neoplasms

Intervention

Drug:
• BIWA 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		up to 6 weeks after infusion	No
Primary	Number of patients with abnormal changes in laboratory parameters		up to 6 weeks after infusion	No
Primary	Number of patients with clinically significant changes in vital signs		up to 6 weeks after infusion	No
Primary	Presence of Human-Anti-Human-Antibody (HAHA)		up to 6 weeks after infusion	No
Primary	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	No
Primary	AUC0-8 (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	No
Primary	Cmax (Maximum measured concentration of the analyte in plasma)		up to 240 hours after infusion	No
Primary	tmax (Time from dosing to the maximum concentration of the analyte in plasma)		up to 240 hours after infusion	No
Primary	t½ (Terminal half-life of the analyte in plasma)		up to 240 hours after infusion	No
Primary	MRT (Mean residence time of the analyte in the body)		up to 240 hours after infusion	No
Primary	Vss (Apparent volume of distribution under steady state conditions)		up to 240 hours after infusion	No
Primary	Vz (Apparent volume of distribution during the terminal phase)		up to 240 hours after infusion	No
Primary	CL (Total body clearance)		up to 240 hours after infusion	No
Primary	Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples	expressed as %ID/kg	at 72 hours after infusion	No
Primary	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	No

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