Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Non-small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204059
• Other study ID #: 1170.3
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2014
• Last updated: July 29, 2014
• Start date: December 1999

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 is to assess the safety and tolerability of intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in patients with non-small cell lung cancer (NSCLC)

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 Non small cell lung cancer (NSCLC) stage I, II or IIIa according to the staging system of the American Joint Committee on Cancer (AJCC)

• Patients destined for resection of the tumour

• 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 Electrocardiogram (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 and 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

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• hMAb 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 post infusion	No
Primary	Number of patients with abnormal changes in laboratory parameters		up to 6 weeks post infusion	No
Primary	Number of patients with clinically significant changes in vital signs		up to 6 weeks post infusion	No
Primary	Presence of Human-Anti-Human-Antibody (HAHA)		up to 6 weeks post infusion	No
Primary	Biodistribution of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples	assessed by radioimmunoscintigraphy expressed as no, low, medium or high	up to 96 hours post 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
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 6 weeks post infusion	No
Primary	Cmax (Maximum measured concentration of the analyte in plasma)		up to 6 weeks post infusion	No
Primary	tmax (Time from dosing to the maximum concentration of the analyte in plasma)		up to 6 weeks post infusion	No
Primary	t½ (Terminal half-life of the analyte in plasma)		up to 6 weeks post infusion	No
Primary	MRT (Mean residence time of the analyte in the body)		up to 6 weeks post infusion	No
Primary	Vss (Apparent volume of distribution under steady state conditions)		up to 6 weeks post infusion	No
Primary	Vz (Apparent volume of distribution during the terminal phase)		up to 6 weeks post infusion	No
Primary	CL (Total body clearance)		up to 6 weeks post infusion	No

External Links

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