Breast NeoplasmsPhase 1NCT02254031
Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer
A Phase 1 study testing bivatuzumab mertansine in people with Breast Neoplasms, run by Boehringer Ingelheim.
Trial summary
maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- bivatuzumab mertansine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2003to 1 Jan 2005
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients aged 18 years or older
- patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
- patients with local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
- measurable tumour deposits by one or more radiological techniques (MRI, CT)
- life expectancy of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- patients must have given written informed consent (which must be consistent with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)
Who cannot join
- hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
- known secondary malignancy requiring therapy
- active infectious disease
- brain metastases requiring therapy
- neuropathy grade 2 or above
- absolute neutrophil count less than 1,500/mm3
Show all 17Show fewer
- platelet count less than 100,000/mm3
- bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent)
- aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
- serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)
- concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
- chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
- radiotherapy to breast and thorax region within the past four weeks prior to treatment with the trial drug or during the trial
- women who are sexually active and unwilling to use a medically acceptable method of contraception
- pregnancy or lactation
- treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- patients unable to comply with the protocol
About this study
Official title: An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer With Repeated Administration Courses in Patients With Clinical Benefit
maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
- Conditions
- Breast Neoplasms
- Being tested
- bivatuzumab mertansine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivatuzumab mertansineDrug
| Study group | Role | What they receive |
|---|---|---|
| bivatuzumab mertansine | Experimental | dose escalation Receives: Drug: bivatuzumab mertansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: up to 6 months
Secondary outcomes (19)
Incidence of adverse events
graded according to common toxicity criteria (CTC)
Measured: up to 14 days after last drug administration
Number of patients with clinically significant findings in laboratory examinations
Measured: up to 14 days after last drug administration
Number of patients with clinically significant findings in vital signs
Measured: up to 14 days after last drug administration
Number of patients with development of Human Anti-Human Antibody (HAHA)
Measured: up to 14 days after last drug administration
Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)
Measured: up to 168 hours
Area under the serum concentration time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz)
Measured: up to 14 days after last drug administration
Area under the serum concentration time curve from time point zero to infinity (AUC0-∞)
Measured: up to 14 days after last drug administration
Maximum serum concentration (Cmax)
Measured: up to 14 days after last drug administration
Time to reach maximum serum concentration (tmax)
Measured: up to 14 days after last drug administration
Terminal elimination half-life (t1/2)
Measured: up to 14 days after last drug administration
Mean residence time (MRT)
Measured: up to 14 days after last drug administration
Total body clearance (CL)
Measured: up to 14 days after last drug administration
Volume of distribution at steady state (Vss)
Measured: up to 14 days after last drug administration
Volume of distribution during the terminal elimination phase (Vz)
Measured: up to 14 days after last drug administration
Trough concentration at steady state (Cpre,ss)
Measured: up to 7 days after drug administration
Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss)
Measured: up to 7 days after drug administration
Linearity index (LI)
Measured: up to 14 days after last drug administration
Accumulation factor (RA)
Measured: up to 14 days after last drug administration
Tumor response
according to response evaluation criteria in solid tumours (RECIST)
Measured: up to 14 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study start1 Jul 2003
- Primary completion1 Jan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT02254031
- Sponsor's protocol ID
- 1191.3
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2014
- Last updated
- 24 Oct 2023
- Results posted
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer With Repeated Administration Courses in Patients With Clinical Benefit
- ClinicalTrials.gov ID
- NCT02254031
- Acronym / sponsor ID
- 1191.3
- Conditions
- Breast Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2003 (actual)
- Primary completion
- 1 Jan 2005 (actual)
- First posted
- 1 Oct 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.
maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bivatuzumab mertansine | Experimental | Drug: bivatuzumab mertansinedose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- female patients aged 18 years or older
- patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
- patients with local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
- measurable tumour deposits by one or more radiological techniques (MRI, CT)
- life expectancy of at least 6 months
Key exclusion criteria (17 listed)
- hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
- known secondary malignancy requiring therapy
- active infectious disease
- brain metastases requiring therapy
- neuropathy grade 2 or above
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 |
|---|---|---|
| bivatuzumab mertansine | Drug | bivatuzumab mertansine |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: up to 6 months
19 secondary outcomes
Incidence of adverse events
Time frame: up to 14 days after last drug administration
Number of patients with clinically significant findings in laboratory examinations
Time frame: up to 14 days after last drug administration
Number of patients with clinically significant findings in vital signs
Time frame: up to 14 days after last drug administration
Number of patients with development of Human Anti-Human Antibody (HAHA)
Time frame: up to 14 days after last drug administration
Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)
Time frame: up to 168 hours
Area under the serum concentration time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz)
Time frame: up to 14 days after last drug administration
Area under the serum concentration time curve from time point zero to infinity (AUC0-∞)
Time frame: up to 14 days after last drug administration
Maximum serum concentration (Cmax)
Time frame: up to 14 days after last drug administration
Time to reach maximum serum concentration (tmax)
Time frame: up to 14 days after last drug administration
Terminal elimination half-life (t1/2)
Time frame: up to 14 days after last drug administration
Mean residence time (MRT)
Time frame: up to 14 days after last drug administration
Total body clearance (CL)
Time frame: up to 14 days after last drug administration
Volume of distribution at steady state (Vss)
Time frame: up to 14 days after last drug administration
Volume of distribution during the terminal elimination phase (Vz)
Time frame: up to 14 days after last drug administration
Trough concentration at steady state (Cpre,ss)
Time frame: up to 7 days after drug administration
Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss)
Time frame: up to 7 days after drug administration
Linearity index (LI)
Time frame: up to 14 days after last drug administration
Accumulation factor (RA)
Time frame: up to 14 days after last drug administration
Tumor response
Time frame: up to 14 days after last drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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 bivatuzumab mertansine in people with Breast Neoplasms, 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 17 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: stopped early, as of the sponsor's last update on 24 Oct 2023. 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 was stopped early. Results are not available in the source record.
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?
Maximum tolerated dose (MTD) (time frame: up to 6 months). 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 24 Oct 2023.