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

Primary Purpose

Adenocarcinoma

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

BIWA 4

About this trial

This is an interventional treatment trial for Adenocarcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIWA 4

Arm Description

Generic Name: Bivatuzumab 186Re-labelled humanised monoclonal antibody BIWA 4

Outcomes

Primary Outcome Measures

Number of patients with adverse events

Number of patients with abnormal changes in laboratory parameters

Number of patients with clinically significant changes in vital signs

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

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

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

AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Cmax (Maximum measured concentration of the analyte in plasma)

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

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

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

Vss (Apparent volume of distribution under steady state conditions)

Vz (Apparent volume of distribution during the terminal phase)

CL (Total body clearance)

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

expressed as %ID/kg

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT02204046

First Posted

July 29, 2014

Last Updated

July 29, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02204046

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

February 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIWA 4

Arm Type

Experimental

Arm Description

Generic Name: Bivatuzumab 186Re-labelled humanised monoclonal antibody BIWA 4

Intervention Type

Drug

Intervention Name(s)

BIWA 4

Primary Outcome Measure Information:

Title

Number of patients with adverse events

Time Frame

up to 6 weeks after infusion

Title

Number of patients with abnormal changes in laboratory parameters

Time Frame

up to 6 weeks after infusion

Title

Number of patients with clinically significant changes in vital signs

Time Frame

up to 6 weeks after infusion

Title

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

Time Frame

up to 6 weeks after infusion

Title

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

Description

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

Time Frame

up to 72 hours after infusion

Title

AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Time Frame