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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254044
Recruitment Status : Terminated
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
Carcinoma, Squamous Cell Drug: bivatuzumab mertansine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2003
Actual Primary Completion Date : November 2004

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 14 days after last drug administration ]
    graded according to common toxicity criteria (CTC)

  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 [ Time Frame: up to 14 days after last drug administration ]
    according to response evaluation criteria in solid tumours (RECIST)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254044    
Other Study ID Numbers: 1191.4
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
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
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