Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus

September 30, 2014 updated by: Boehringer Ingelheim

An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus With Repeated Administration Courses in Patients With Clinical Benefit

maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients from 18 to 80 years of age (both inclusive)
  2. patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
  3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
  4. evaluable tumour deposits
  5. life expectancy of at least 3 months
  6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
  7. patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)

Exclusion Criteria:

  1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
  2. known secondary malignancy requiring therapy
  3. active infectious disease
  4. brain metastases requiring therapy
  5. neuropathy grade 2 or above
  6. absolute neutrophil count less than 1,500/mm3
  7. platelet count less than 100,000/mm3
  8. bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent)
  9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
  10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)
  11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
  12. chemo-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
  13. men and women who are sexually active and unwilling to use a medically acceptable method of contraception
  14. pregnancy or lactation
  15. 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)
  16. patients unable to comply with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: bivatuzumab mertansine
dose escalation
Drug: bivatuzumab mertansine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum tolerated dose (MTD)
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: up to 14 days after last drug administration
graded according to common toxicity criteria (CTC)
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
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
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
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
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
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
up to 14 days after last drug administration
Maximum serum concentration (Cmax)
Time Frame: up to 14 days after last drug administration
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
up to 14 days after last drug administration
Terminal elimination half-life (t1/2)
Time Frame: up to 14 days after last drug administration
up to 14 days after last drug administration
Mean residence time (MRT)
Time Frame: up to 14 days after last drug administration
up to 14 days after last drug administration
Total body clearance (CL)
Time Frame: up to 14 days after last drug administration
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
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
up to 14 days after last drug administration
Trough concentration at steady state (Cpre,ss)
Time Frame: up to 7 days after drug administration
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
up to 7 days after drug administration
Linearity index (LI)
Time Frame: up to 14 days after last drug administration
up to 14 days after last drug administration
Accumulation factor (RA)
Time Frame: up to 14 days after last drug administration
up to 14 days after last drug administration
Tumor response
Time Frame: up to 14 days after last drug administration
according to response evaluation criteria in solid tumours (RECIST)
up to 14 days after last drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1191.4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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