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TerminatedNCT02254044Updated Oct 1, 2014

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

A Phase 1 interventional study of bivatuzumab mertansine in Carcinoma, Squamous Cell, sponsored by Boehringer Ingelheim. Terminated. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Carcinoma, Squamous Cell
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 7 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    bivatuzumab mertansine

    dose escalation

    Drug: bivatuzumab mertansine

Interventions

  • Drugbivatuzumab mertansine
06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: up to 6 months

Secondary outcomes

  1. Incidence of adverse events

    graded according to common toxicity criteria (CTC)

    Time frame: up to 14 days after last drug administration

  2. Number of patients with clinically significant findings in laboratory examinations

    Time frame: up to 14 days after last drug administration

  3. Number of patients with clinically significant findings in vital signs

    Time frame: up to 14 days after last drug administration

  4. Number of patients with development of Human Anti-Human Antibody (HAHA)

    Time frame: up to 14 days after last drug administration

  5. Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)

    Time frame: up to 168 hours

  6. 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

  7. Area under the serum concentration time curve from time point zero to infinity (AUC0-∞)

    Time frame: up to 14 days after last drug administration

  8. Maximum serum concentration (Cmax)

    Time frame: up to 14 days after last drug administration

  9. Time to reach maximum serum concentration (tmax)

    Time frame: up to 14 days after last drug administration

  10. Terminal elimination half-life (t1/2)

    Time frame: up to 14 days after last drug administration

  11. Mean residence time (MRT)

    Time frame: up to 14 days after last drug administration

  12. Total body clearance (CL)

    Time frame: up to 14 days after last drug administration

  13. Volume of distribution at steady state (Vss)

    Time frame: up to 14 days after last drug administration

  14. Volume of distribution during the terminal elimination phase (Vz)

    Time frame: up to 14 days after last drug administration

  15. Trough concentration at steady state (Cpre,ss)

    Time frame: up to 7 days after drug administration

  16. Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss)

    Time frame: up to 7 days after drug administration

  17. Linearity index (LI)

    Time frame: up to 14 days after last drug administration

  18. Accumulation factor (RA)

    Time frame: up to 14 days after last drug administration

  19. Tumor response

    according to response evaluation criteria in solid tumours (RECIST)

    Time frame: up to 14 days after last drug administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02254044
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 1, 2014
Start date
Oct 2003
Primary completion
Nov 2004
Last update
Oct 1, 2014
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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