Breast NeoplasmsPhase 1NCT02254005

Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer

A Phase 1 study testing bivatuzumab mertansine in people with Breast Neoplasms, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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: 24 participants
Where: No sites listed yet
Study dates: 1 Oct 2002to 1 Dec 2004
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 metastases pretreated with anthracyclines and 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 on 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 common toxicity criteria (CTC) 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 before inclusion 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 Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Female Patients With CD44v6 Positive Metastatic Breast Cancer With Repeated Administration 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 groups in NCT02254005
Study group	Role	What they receive
single dose escalation	Experimental	Not described 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)

Incidence of adverse events
Measured: up to day 21
Number of patients with clinically significant findings in laboratory tests
Measured: up to day 21
Number of patients with clinically significant findings in vital signs
Measured: up to day 21
Tumor response rate
assessed by 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.

1 Oct 20021 Dec 2004

First posted1 Oct 2014 (estimated)
Study start1 Oct 2002
Primary completion1 Dec 2004

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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02254005
Sponsor's protocol ID: 1191.1
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Neoplasms trials

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 Female Patients With CD44v6 Positive Metastatic Breast Cancer With Repeated Administration in Patients With Clinical Benefit
ClinicalTrials.gov ID: NCT02254005
Acronym / sponsor ID: 1191.1
Conditions: Breast Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Oct 2002 (actual)
Primary completion: 1 Dec 2004 (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
single dose escalation	Experimental	Drug: bivatuzumab mertansine

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 metastases pretreated with anthracyclines and 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 common toxicity criteria (CTC) 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	single dose escalation

Primary outcome

Maximum tolerated dose (MTD) of bivatuzumab mertansine
Time frame: up to day 21

7 secondary outcomes

Incidence of adverse events
Time frame: up to day 21
Number of patients with clinically significant findings in laboratory tests
Time frame: up to day 21
Number of patients with clinically significant findings in vital signs
Time frame: up to day 21
Tumor response rate
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

Related trials for Breast Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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: 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?

On the ClinicalTrials.gov record for NCT02254005.

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.