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Randomized discontinuation trial of sorafenib (BAY 43-9006)
Lokesh Jain1, Jürgen Venitz, William D Figg
1Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, USA.
Abstract:
With the increasing interest in development of cytostatic anticancer drugs, the randomized discontinuation trial (RDT) design has been proved to be useful in the evaluation of their clinical activity. In the June 1, 2006 issue of the Journal of Clinical Oncology, a study by Ratain et al. uses RDT in a phase-II placebo controlled study to evaluate the efficacy of sorafenib (BAY 43-9006) in patients with metastatic renal cell carcinoma (RCC). The results from their investigation affirm the merits of the RDT in testing the efficacy of cytostatic drugs and also prove the significant disease-stabilizing activity and tolerability of sorafenib in metastatic renal cell carcinoma.
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