Head and Neck Neoplasms
Conditions
Brief summary
maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) of bivatuzumab mertansine | up to day 21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with clinically significant changes in laboratory parameters | up to day 21 | — |
| Number of patients with clinically significant changes in vital signs | up to day 21 | — |
| Tumor response | up to 1 year | according to the response evaluation criteria in solid tumours (RECIST) |
| Number of patients with adverse events | up to day 21 | grading according to the common toxicity criteria (CTC) |
| Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG) | up to day 21 | — |
| Number of patients with development of human anti-human antibodies (HAHA) | up to day 21 | — |
| Concentration of bivatuzumab mertansine | up to day 21 | — |
Outcome results
None listed