Randomized discontinuation trial of sorafenib (BAY 43-9006).
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.
Jain
Lokesh
L
Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, USA.
Venitz
Jürgen
J
Figg
William D
WD
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy*; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D010919:Placebos; D011725:Pyridines / Q000627:therapeutic use*; D015203:Reproducibility of Results; D012107:Research Design; D000077157:Sorafenib; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D010919:Placebos; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib