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

Carcinoma, Squamous Cell Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02254044
• Other study ID #: 1191.4
• Status: Terminated
• Phase: Phase 1
• First received: September 30, 2014
• Last updated: September 30, 2014
• Start date: October 2003

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Drug:
• bivatuzumab mertansine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)		up to 6 months	No
Secondary	Incidence of adverse events	graded according to common toxicity criteria (CTC)	up to 14 days after last drug administration	No
Secondary	Number of patients with clinically significant findings in laboratory examinations		up to 14 days after last drug administration	No
Secondary	Number of patients with clinically significant findings in vital signs		up to 14 days after last drug administration	No
Secondary	Number of patients with development of Human Anti-Human Antibody (HAHA)		up to 14 days after last drug administration	No
Secondary	Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)		up to 168 hours	No
Secondary	Area under the serum concentration time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz)		up to 14 days after last drug administration	No
Secondary	Area under the serum concentration time curve from time point zero to infinity (AUC0-8)		up to 14 days after last drug administration	No
Secondary	Maximum serum concentration (Cmax)		up to 14 days after last drug administration	No
Secondary	Time to reach maximum serum concentration (tmax)		up to 14 days after last drug administration	No
Secondary	Terminal elimination half-life (t1/2)		up to 14 days after last drug administration	No
Secondary	Mean residence time (MRT)		up to 14 days after last drug administration	No
Secondary	Total body clearance (CL)		up to 14 days after last drug administration	No
Secondary	Volume of distribution at steady state (Vss)		up to 14 days after last drug administration	No
Secondary	Volume of distribution during the terminal elimination phase (Vz)		up to 14 days after last drug administration	No
Secondary	Trough concentration at steady state (Cpre,ss)		up to 7 days after drug administration	No
Secondary	Minimum serum concentration during the dosing interval t at steady state (Cmin,ss)		up to 7 days after drug administration	No
Secondary	Linearity index (LI)		up to 14 days after last drug administration	No
Secondary	Accumulation factor (RA)		up to 14 days after last drug administration	No
Secondary	Tumor response	according to response evaluation criteria in solid tumours (RECIST)	up to 14 days after last drug administration	No

External Links

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