AdenocarcinomaPhase 1NCT02204046
Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Adenocarcinoma of the Breast
A Phase 1 study testing BIWA 4 in people with Adenocarcinoma, run by Boehringer Ingelheim.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- BIWA 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Feb 2001
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Adenocarcinoma of the Breast
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
- Conditions
- Adenocarcinoma
- Being tested
- BIWA 4
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIWA 4Drug
| Study group | Role | What they receive |
|---|---|---|
| BIWA 4 | Experimental | Generic Name: Bivatuzumab
186Re-labelled humanised monoclonal antibody BIWA 4 Receives: Drug: BIWA 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 6 weeks after infusion
Number of patients with abnormal changes in laboratory parameters
Measured: up to 6 weeks after infusion
Number of patients with clinically significant changes in vital signs
Measured: up to 6 weeks after infusion
Presence of Human-Anti-Human-Antibody (HAHA)
Measured: up to 6 weeks after infusion
Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
Assessment of biodistribution by radioscintigraphy expressed as low, medium or high
Measured: up to 72 hours after infusion
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 240 hours after infusion
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 240 hours after infusion
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 240 hours after infusion
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 240 hours after infusion
MRT (Mean residence time of the analyte in the body)
Measured: up to 240 hours after infusion
Vss (Apparent volume of distribution under steady state conditions)
Measured: up to 240 hours after infusion
Vz (Apparent volume of distribution during the terminal phase)
Measured: up to 240 hours after infusion
CL (Total body clearance)
Measured: up to 240 hours after infusion
Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
expressed as %ID/kg
Measured: at 72 hours after 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)
Measured: after surgery on day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJan 2000
- Primary completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204046
- Sponsor's protocol ID
- 1170.2
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 30 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Adenocarcinoma of the Breast
- ClinicalTrials.gov ID
- NCT02204046
- Acronym / sponsor ID
- 1170.2
- Conditions
- Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- Feb 2001 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIWA 4 | Experimental | Drug: BIWA 4Generic Name: Bivatuzumab 186Re-labelled humanised monoclonal antibody BIWA 4 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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'
Key exclusion criteria (7 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIWA 4 | Drug | BIWA 4 |
Primary outcome
Number of patients with adverse events
Time frame: up to 6 weeks after infusion
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 6 weeks after infusion
Number of patients with clinically significant changes in vital signs
Time frame: up to 6 weeks after infusion
Presence of Human-Anti-Human-Antibody (HAHA)
Time frame: up to 6 weeks after infusion
Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
Time frame: up to 72 hours after infusion
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)
Time frame: up to 240 hours after infusion
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 240 hours after infusion
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 240 hours after infusion
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 240 hours after infusion
MRT (Mean residence time of the analyte in the body)
Time frame: up to 240 hours after infusion
Vss (Apparent volume of distribution under steady state conditions)
Time frame: up to 240 hours after infusion
Vz (Apparent volume of distribution during the terminal phase)
Time frame: up to 240 hours after infusion
CL (Total body clearance)
Time frame: up to 240 hours after infusion
Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
Time frame: at 72 hours after infusion
expressed as %ID/kg
Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
Time frame: after surgery on day 8
Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIWA 4 in people with Adenocarcinoma, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: up to 6 weeks after infusion). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.