search
Back to results

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

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
bivatuzumab mertansine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. male and female patients aged 18 years or older
  2. patients with histologically confirmed squamous cell carcinoma of the head and neck
  3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
  4. measurable tumour deposits by one or more radiological techniques (MRI, CT)
  5. life expectancy of at least 6 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 of 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
  5. neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)
  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- or immunotherapy within the past three weeks prior to treatment with the trial drug or during the trial
  13. radiotherapy to head and neck region within the past four weeks before inclusion or during the trial
  14. men and women who are sexually active and unwilling to use a medically acceptable method of contraception
  15. pregnancy or lactation
  16. 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
  17. patients unable to comply with the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    bivatuzumab mertansine

    Arm Description

    single dose escalation

    Outcomes

    Primary Outcome Measures

    Maximum tolerated dose (MTD) of bivatuzumab mertansine

    Secondary Outcome Measures

    Number of patients with adverse events
    grading according to the common toxicity criteria (CTC)
    Number of patients with clinically significant changes in laboratory parameters
    Number of patients with clinically significant changes in vital signs
    Tumor response
    according to the response evaluation criteria in solid tumours (RECIST)
    Concentration of bivatuzumab mertansine
    Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)
    Number of patients with development of human anti-human antibodies (HAHA)

    Full Information

    First Posted
    September 30, 2014
    Last Updated
    October 23, 2023
    Sponsor
    Boehringer Ingelheim
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02254018
    Brief Title
    Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2002 (Actual)
    Primary Completion Date
    February 1, 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    bivatuzumab mertansine
    Arm Type
    Experimental
    Arm Description
    single dose escalation
    Intervention Type
    Drug
    Intervention Name(s)
    bivatuzumab mertansine
    Primary Outcome Measure Information:
    Title
    Maximum tolerated dose (MTD) of bivatuzumab mertansine
    Time Frame
    up to day 21
    Secondary Outcome Measure Information:
    Title
    Number of patients with adverse events
    Description
    grading according to the common toxicity criteria (CTC)
    Time Frame
    up to day 21
    Title
    Number of patients with clinically significant changes in laboratory parameters
    Time Frame
    up to day 21
    Title
    Number of patients with clinically significant changes in vital signs
    Time Frame
    up to day 21
    Title
    Tumor response
    Description
    according to the response evaluation criteria in solid tumours (RECIST)
    Time Frame
    up to 1 year
    Title
    Concentration of bivatuzumab mertansine
    Time Frame
    up to day 21
    Title
    Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)
    Time Frame
    up to day 21
    Title
    Number of patients with development of human anti-human antibodies (HAHA)
    Time Frame
    up to day 21

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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
    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs