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

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ClinicalTrials.gov Identifier: NCT02254018
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: bivatuzumab mertansine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2002
Actual Primary Completion Date : February 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: bivatuzumab mertansine
single dose escalation
Drug: bivatuzumab mertansine



Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of bivatuzumab mertansine [ Time Frame: up to day 21 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254018    
Other Study ID Numbers: 1191.2
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Maytansine
Bivatuzumab mertansine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological