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

NCT02204059 | Completed Phase 1

• 1 other identifier: 1170.3
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (14)

• Number of patients with adverse events

  up to 6 weeks post infusion

• Number of patients with abnormal changes in laboratory parameters

  up to 6 weeks post infusion

• Number of patients with clinically significant changes in vital signs

  up to 6 weeks post infusion

• Presence of Human-Anti-Human-Antibody (HAHA)

  up to 6 weeks post infusion

• 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

• 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

• AUC0-∞ (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

• Cmax (Maximum measured concentration of the analyte in plasma)

  up to 6 weeks post infusion

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

  up to 6 weeks post infusion

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

  up to 6 weeks post infusion

• MRT (Mean residence time of the analyte in the body)

  up to 6 weeks post infusion

• Vss (Apparent volume of distribution under steady state conditions)

  up to 6 weeks post infusion

• Vz (Apparent volume of distribution during the terminal phase)

  up to 6 weeks post infusion

• CL (Total body clearance)

  up to 6 weeks post infusion

Study Arms (1)

hMAb BIWA 4

EXPERIMENTAL

Bivatuzumab: 186 Re-labelled humanised monoclonal antibody BIWA 4

Drug: hMAb BIWA 4

Interventions

hMAb BIWA 4 DRUG

hMAb 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 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

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 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: December 1, 1999
• Primary Completion: February 1, 2001
• Last Updated: July 30, 2014

Record last verified: 2014-07