This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib. The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Novo Nordisk Investigational Site
Frankfurt, Germany
Novo Nordisk Investigational Site
Hamburg, Germany
Novo Nordisk Investigational Site
Hanover, Germany
Novo Nordisk Investigational Site
Amsterdam, Netherlands
Toxicity according to CTCAE version 3.0
Time frame: For the duration of the trial
Pharmacokinetics
Time frame: For the duration of the trial
rIL-21 antibodies
Time frame: For the duration of the trial
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30 mcg/kg, s.c. injection
100 mcg/kg, s.c. injection
Novo Nordisk Investigational Site
Nijmegen, Netherlands