Zalutumumab PK in SCCHN

• Research type

  Research Study

• Full title

  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

• IRAS ID

  31919

• Contact name

  John Chester

• Sponsor organisation

  INC Research

• Eudract number

  2009-013317-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is to look at the Pharmacokinetics (PK) of Zalutumumab in patients with Head and Neck Cancer. PK is the study of how a drug is absorbed (taken up), distributed (moved around), metabolised (broken down) and excreted (removed) by the body, in relation to time. 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.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/113

• Date of REC Opinion

  7 Dec 2009

• REC opinion

  Further Information Favourable Opinion