ZymoGenetics Initiates Phase II Renal Cell Cancer Trial
Posted on: Wednesday, 9 January 2008, 12:01 CST
ZymoGenetics has initiated Phase II testing of Interleukin 21 in combination with Nexavar tablets, in patients with advanced renal cell cancer.
The primary objective of the open label multi-center Phase II study is to characterize safety of Interleukin 21 (IL-21) with Nexavar at the recommended dose; a secondary objective is to evaluate anti-tumor activity, which will be assessed by evaluating tumor response and progression free survival. The trial is expected to enroll approximately 30 patients. The study is evaluating the combination in patients with clear cell carcinoma, which accounts for 85% of all renal cell tumors.
The Phase II study is part of a Phase I/II clinical trial and will examine patients treated with the maximum tolerated dose identified in the recently completed Phase I dose escalation phase.
Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: "In Phase II, we'll continue to evaluate the tolerability and anti-tumor activity of this combination therapy in patients with late stage renal cell cancer."
Source: Datamonitor
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