Clinical trial NCT02204059: Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Non-small Cell Lung Cancer
Official title: A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 6 weeks post infusion
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: up to 6 weeks post infusion
measure: Number of patients with clinically significant changes in vital signs
timeFrame: up to 6 weeks post infusion
measure: Presence of Human-Anti-Human-Antibody (HAHA)
timeFrame: up to 6 weeks post infusion
measure: Biodistribution of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
timeFrame: up to 96 hours post infusion
measure: Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
timeFrame: after surgery on day 8
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 6 weeks post infusion
measure: Cmax (Maximum measured concentration of the analyte in plasma)
timeFrame: up to 6 weeks post infusion
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: up to 6 weeks post infusion
measure: t½ (Terminal half-life of the analyte in plasma)
timeFrame: up to 6 weeks post infusion
measure: MRT (Mean residence time of the analyte in the body)
timeFrame: up to 6 weeks post infusion
measure: Vss (Apparent volume of distribution under steady state conditions)
timeFrame: up to 6 weeks post infusion
measure: Vz (Apparent volume of distribution during the terminal phase)
timeFrame: up to 6 weeks post infusion
measure: CL (Total body clearance)
timeFrame: up to 6 weeks post infusion
Secondary outcomes:
Other outcomes:
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Study officials:
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