Trial Information

A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered Concomitantly With Sorafenib (Nexavar) in Subjects With Metastatic Renal Cell Carcinoma

This is a Phase 1/2 open-label dose-escalation study of rIL-21 given in combination with
sorafenib to patients with metastatic RCC. The Phase 1 part of this study will estimate the
maximum tolerated dose of rIL-21 given for 1 treatment course (consisting of two 5-day
cycles of rIL-21) in combination with a standard dose of sorafenib administered during a
6-week treatment course. Increasing doses of rIL-21 will be studied sequentially in
different groups of patients. The Phase 2 part of the study will further evaluate the safety
and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in
combination with sorafenib. Patients will be evaluated for safety over the course of the
study. Disease evaluation (tumor restaging) will be performed during the last week of each
6-week treatment course. Patients with stable disease or better at this evaluation may go on
to receive additional treatment courses. Patients may be in the study for 2 to 7 months.