The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Weekly infusion
Århus Kommunehospital
Århus C, Denmark
Rigshospitalet
Copenhagen Ø, Denmark
Odense Universitetshospital
Odense, Denmark
Universitets Sjukhuset i Lund
Lund, Sweden
Uppsala Akademiska Sjukhus
Adverse Events
Number of participants reporting at least one adverse event.
Time frame: From study start (Day 0) until follow-up period (up to Day 77)
Overall Response (OR), Classification
Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
Time frame: 8 weeks
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Uppsala, Sweden