Status:
COMPLETED
Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
Eligibility Criteria
Inclusion
- male and female patients aged 18 years or older
- patients with histologically confirmed squamous cell carcinoma of the head and neck
- patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
- measurable tumour deposits by one or more radiological techniques (MRI, CT)
- life expectancy of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- 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
- hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
- known secondary malignancy requiring therapy
- active infectious disease
- brain metastases
- neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)
- 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- or immunotherapy within the past three weeks prior to treatment with the trial drug or during the trial
- radiotherapy to head and neck region within the past four weeks before inclusion or during the trial
- 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 three weeks before start of therapy or concomitantly with this trial
- patients unable to comply with the protocol
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02254018
Start Date
September 1 2002
Last Update
October 24 2023
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