An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic Profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Non-curable Patients With SCCHN
This study is to look at the Pharmacokinetics (PK) of Zalutumumab in patients with Head and
Neck Cancer. 26 participants will be treated with the study drug Zalutumumab at 4 different
doses. Zalutumumab will be given at day 0, day 14, day 21 and day 28. Blood samples (for PK
and to check the participant's safety) will be taken before drug is given. Blood samples for
PK only will be taken directly after drug is given at all treatment visits and also at +3hr
and +12hrs on day 0 and day 28 which may require an overnight stay.
Blood samples for PK only are also taken on days between treatments. After treatment on day
28, eight more blood samples will be taken over 3 weeks. On day 49 participants may enter an
optional extended treatment period receiving the drug weekly until it is no longer
appropriate for the participant (doctor/participant decision or cancer has advanced).
Dosing in the extended treatment period will start at 16mg/kg. The correct dose for the
participant will be checked at each visit by looking for the presence and severity of skin
rash. This is a common side effect of medicines like Zalutumumab which block the Epidermal
Growth Factor Receptor. The severity of the skin rash is used as a guide for dosing. A mild
rash could mean more medication is needed, a severe rash will mean the participant needs a
break from the medication. End of study is 8 weeks after the last dose of Zalutumumab and
blood samples will be taken +4weeks and +8weeks after the last dose of drug.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To look at the Pharmacokinetics of Zalutumumab in patients with Cancer of the Head and Neck.
PK samples are taken: pre and post infusion on days 0, 14, 21 and 28 plus at +3 and +12 hours on days 0 and 28. A single PK sample is taken on days between these treatments and 8 more are taken over 3 weeks after treatment on day 28.
PK samples are taken: pre and post infusion on days 0, 14, 21 and 28 plus at +3 and +12 hours on days 0 and 28. A single PK sample is taken on days between these treatments and 8 more are taken over 3 weeks after treatment on day 28.
Yes
Jean-Pascal Machiels, MD, PhD
Principal Investigator
Cliniques Universitaires SaintLuc, Belgium
United Kingdom: Medicines and Healthcare Products Regulatory Agency
GEN211
NCT01054625
March 2010
October 2011
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