Back to resultsDose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus
Primary Purpose
Carcinoma, Squamous Cell
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
bivatuzumab mertansine
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Squamous Cell
Eligibility Criteria
Inclusion Criteria:
- patients from 18 to 80 years of age (both inclusive)
- patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
- patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
- evaluable tumour deposits
- life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- 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:
- hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
- known secondary malignancy requiring therapy
- active infectious disease
- brain metastases requiring therapy
- neuropathy grade 2 or above
- 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-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
- 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 four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- patients unable to comply with the protocol
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bivatuzumab mertansine
Arm Description
dose escalation
Outcomes
Primary Outcome Measures
Maximum tolerated dose (MTD)
Secondary Outcome Measures
Incidence of adverse events
graded according to common toxicity criteria (CTC)
Number of patients with clinically significant findings in laboratory examinations
Number of patients with clinically significant findings in vital signs
Number of patients with development of Human Anti-Human Antibody (HAHA)
Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)
Area under the serum concentration time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz)
Area under the serum concentration time curve from time point zero to infinity (AUC0-∞)
Maximum serum concentration (Cmax)
Time to reach maximum serum concentration (tmax)
Terminal elimination half-life (t1/2)
Mean residence time (MRT)
Total body clearance (CL)
Volume of distribution at steady state (Vss)
Volume of distribution during the terminal elimination phase (Vz)
Trough concentration at steady state (Cpre,ss)
Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss)
Linearity index (LI)
Accumulation factor (RA)
Tumor response
according to response evaluation criteria in solid tumours (RECIST)
Full Information
NCT ID
NCT02254044
First Posted
September 30, 2014
Last Updated
September 30, 2014
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02254044
Brief Title
Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus
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 Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Study Start Date
October 2003 (undefined)
Primary Completion Date
November 2004 (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
Carcinoma, Squamous Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bivatuzumab mertansine
Arm Type
Experimental
Arm Description
dose escalation
Intervention Type
Drug
Intervention Name(s)
bivatuzumab mertansine
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
graded according to common toxicity criteria (CTC)
Time Frame
up to 14 days after last drug administration
Title
Number of patients with clinically significant findings in laboratory examinations
Time Frame
up to 14 days after last drug administration
Title
Number of patients with clinically significant findings in vital signs
Time Frame
up to 14 days after last drug administration
Title
Number of patients with development of Human Anti-Human Antibody (HAHA)
Time Frame
up to 14 days after last drug administration
Title
Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)
Time Frame
up to 168 hours
Title
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
Title
Area under the serum concentration time curve from time point zero to infinity (AUC0-∞)
Time Frame
up to 14 days after last drug administration
Title
Maximum serum concentration (Cmax)
Time Frame
up to 14 days after last drug administration
Title
Time to reach maximum serum concentration (tmax)
Time Frame
up to 14 days after last drug administration
Title
Terminal elimination half-life (t1/2)
Time Frame
up to 14 days after last drug administration
Title
Mean residence time (MRT)
Time Frame
up to 14 days after last drug administration
Title
Total body clearance (CL)
Time Frame
up to 14 days after last drug administration
Title
Volume of distribution at steady state (Vss)
Time Frame
up to 14 days after last drug administration
Title
Volume of distribution during the terminal elimination phase (Vz)
Time Frame
up to 14 days after last drug administration
Title
Trough concentration at steady state (Cpre,ss)
Time Frame
up to 7 days after drug administration
Title
Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss)
Time Frame
up to 7 days after drug administration
Title
Linearity index (LI)
Time Frame
up to 14 days after last drug administration
Title
Accumulation factor (RA)
Time Frame
up to 14 days after last drug administration
Title
Tumor response
Description
according to response evaluation criteria in solid tumours (RECIST)
Time Frame
up to 14 days after last drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients from 18 to 80 years of age (both inclusive)
patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
evaluable tumour deposits
life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
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:
hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
known secondary malignancy requiring therapy
active infectious disease
brain metastases requiring therapy
neuropathy grade 2 or above
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-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
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 four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
patients unable to comply with the protocol
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
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Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus
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