An Open-label, International, Multi-Center, Phase I/II, Dose-escalation Trial Investigating the Safety of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Combination With Radiotherapy, in Patients With Stage III, IVa or IVb Locally Advanced Squamous Cell Carcinoma of the Head and Neck Ineligible for Platinum Based Chemotherapy
This is an open label, multi-center, phase I/II dose-escalation clinical trial investigating
the safety of zalutumumab in combination with radiotherapy. The safety of zalutumumab doses
in combination with radiotherapy (RT) will be investigated using 3 patient cohorts in a
dose-escalation / de-escalation design based on Dose Limiting Toxicity (DLT). The
dose-escalation starts at 8 mg/kg zalutumumab in combination with RT. Initially, three
patients will be treated at a dose level and observed for DLTs. If none of the three
patients experience a DLT, then the next cohort of three patients is treated at the next
higher dose of zalutumumab. If one of three patients treated at a dose level experience a
DLT, then three more patients are treated at the same dose level. If two or more of the
three patients experience DLTs, then the next cohort of three patients should be treated at
the next lower dose of zalutumumab, unless at least six patients on that dose have already
been dosed. Furthermore, if 1 or fewer DLTs are observed among six patients at a given dose
level, then the next cohort of three patients is treated at the next higher dose of
zalutumumab. The maximum tolerated dose will be decided by Genmab based on the
recommendations made by the IDMC on the basis of their review of the aggregated safety
data.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse Events
Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.
Overall study
Yes
Philippe MAIGON
Principal Investigator
Centre Georges-François Leclerc
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GEN207
NCT00707655
September 2008
October 2010
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