SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

Summary

The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

Timeline

Start

2004-08

Primary completion

2008-09

Completion

2008-09

Outcome

Met primary endpoint

registry MEDIAN SU011248: 48.3 (46.4 to 58.3) weeks MEDIAN IFN-α: 22.1 (17.1 to 24.0) weeks NCT00083889 ↗

registry analysis (superiority or other test); SU011248 vs IFN-α; p <0.0001; Hazard Ratio (HR) 0.5268 (95% CI 0.4316 to 0.6430); Log Rank NCT00083889 ↗

Publications

• Rini BI, Hutson TE, Figlin RA, Lechuga MJ, Valota O, Serfass L, Rosbrook B, Motzer RJ. Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group. Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.
• de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
• Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
• Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
• Cella D, Michaelson MD, Bushmakin AG, Cappelleri JC, Charbonneau C, Kim ST, Li JZ, Motzer RJ. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis. Br J Cancer. 2010 Feb 16;102(4):658-64. doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.
• Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sunitinib	Small molecule	50 mg	Oral
Comparator	interferon alfa	Protein / enzyme biologic	9e+06 iu	Subcutaneous

Indications