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OpenTrials
Completed

NCT Number: NCT02254018

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

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

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bivatuzumab mertansine

Drug

Primary outcomes

  1. Maximum tolerated dose (MTD) of bivatuzumab mertansine

    Time frame: up to day 21

Secondary outcomes

  1. Number of patients with adverse events

    Time frame: up to day 21

    grading according to the common toxicity criteria (CTC)

  2. Number of patients with clinically significant changes in laboratory parameters

    Time frame: up to day 21

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

    Time frame: up to day 21

  4. Tumor response

    Time frame: up to 1 year

    according to the response evaluation criteria in solid tumours (RECIST)

  5. Concentration of bivatuzumab mertansine

    Time frame: up to day 21

  6. Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)

    Time frame: up to day 21

  7. Number of patients with development of human anti-human antibodies (HAHA)

    Time frame: up to day 21

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2005
First posted
Oct 1, 2014
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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