Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

July 31, 2011

Study Completion Date

October 31, 2011

Conditions
Head and Neck Cancer
Interventions
BIOLOGICAL

zalutumumab

Zalutumumab is a clear to opalescent liquid. It is intended for intravenous infusion following dilution in sterile, pyrogen free, 0.9% NaCl. Patients will be treated at a specified dose of Zalutumumab over a period of 7 weeks. The dose will be 4mg/kg, 8mg/kg or 16mg/kg depending on when they enter the study. The study will begin with 6 patients on 4mg/kg, then 10 patients on 8mg/kg and lastly 10 patients on 16mg/kg.

Trial Locations (7)

1200

Cliniques Universitaires SaintLuc, Brussels

3000

Uz Leuven - Campus Gasthuisberg, Leuven

9700

Vas Megye es Szombathely, Szombathely

H-1145

Uzsoki Hospital, Budapest

833 10

Narodny onkologicky ustav, Bratislava

917 75

FN Tnava, Trnava

LS9 7TF

St James's Institute of Oncology, Leeds

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genmab

INDUSTRY

NCT01054625 - Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Biotech Hunter | Biotech Hunter