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A randomised clinical trial investigating the effect of dovitinib versus sorafenib in patients with clear cell metastatic renal cell carcinoma who received one previous VEGF-targeted therapy and one previous mTOR inhibitor

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NCT01223027    Lancet Oncol 2014;15:286-96  



Studied treatment dovitinib (500 mg orally according to a 5-days-on and 2-days-off schedule)
Control treatment sorafenib (400 mg orally twice daily)



Patients patients with clear cell metastatic renal cell carcinoma who received one previous VEGF-targeted therapy and one previous mTOR inhibitor
Group sizes284 / 286
treatment line line 2
cross over



Blindness open-label Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint Design



EndpointX1N1X0N0TE95% CI PFS - 284 - 286 0,86[0,72; 1,03] OS - 284 - 286 no data0,22,01,0

Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Gr├╝nwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol 2014;15:286-96     [PMID: 24556040]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT01223027



Registering number NCT01223027 (see trial on clinicaltrials.gov)
Code Name