Head and Neck NeoplasmsPhase 1NCT02254018
Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study testing bivatuzumab mertansine in people with Head and Neck 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
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- bivatuzumab mertansine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2002to 1 Feb 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients aged 18 years or older
- patients with histologically confirmed squamous cell carcinoma of the head and neck
- patients with local and / or regional recurrent disease or distant metastases who are refractory to 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
- neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)
- 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 three weeks prior to treatment with the trial drug or during the trial
- radiotherapy to head and neck region within the past four weeks before inclusion or during the trial
- men and 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 three weeks before start of therapy or concomitantly with this trial
- patients unable to comply with the protocol
About this study
Official title: An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck With Repeated Administration in Patients With Clinical Benefit
maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
- Conditions
- Head and Neck Neoplasms
- Being tested
- bivatuzumab mertansine
- Medical subject headings
- Head and Neck 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 | single 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) of bivatuzumab mertansine
Measured: up to day 21
Secondary outcomes (7)
Number of patients with adverse events
grading according to the common toxicity criteria (CTC)
Measured: up to day 21
Number of patients with clinically significant changes in laboratory parameters
Measured: up to day 21
Number of patients with clinically significant changes in vital signs
Measured: up to day 21
Tumor response
according to the response evaluation criteria in solid tumours (RECIST)
Measured: up to 1 year
Concentration of bivatuzumab mertansine
Measured: up to day 21
Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)
Measured: up to day 21
Number of patients with development of human anti-human antibodies (HAHA)
Measured: up to day 21
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 Sep 2002
- Primary completion1 Feb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck 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
- 31 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
- NCT02254018
- Sponsor's protocol ID
- 1191.2
- 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 Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck With Repeated Administration in Patients With Clinical Benefit
- ClinicalTrials.gov ID
- NCT02254018
- Acronym / sponsor ID
- 1191.2
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2002 (actual)
- Primary completion
- 1 Feb 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 mertansinesingle dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male and female patients aged 18 years or older
- patients with histologically confirmed squamous cell carcinoma of the head and neck
- patients with local and / or regional recurrent disease or distant metastases who are refractory to 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
- neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)
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) of bivatuzumab mertansine
Time frame: up to day 21
7 secondary outcomes
Number of patients with adverse events
Time frame: up to day 21
Number of patients with clinically significant changes in laboratory parameters
Time frame: up to day 21
Number of patients with clinically significant changes in vital signs
Time frame: up to day 21
Tumor response
Time frame: up to 1 year
Concentration of bivatuzumab mertansine
Time frame: up to day 21
Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)
Time frame: up to day 21
Number of patients with development of human anti-human antibodies (HAHA)
Time frame: up to day 21
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 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 Head and Neck 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: finished, 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 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?
Maximum tolerated dose (MTD) of bivatuzumab mertansine (time frame: up to day 21). 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.