drugset / Trial / NCT01024920
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
RandomizedParallel-groupOpen-labelTreatment
Summary
Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).
Timeline
- Start
- 2009-12-16
- Primary completion
- 2011-11-08
- Completion
- 2020-06-19
Publications
- Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
- Eisen T, Shparyk Y, Macleod N, Jones R, Wallenstein G, Temple G, Khder Y, Dallinger C, Studeny M, Loembe AB, Bondarenko I. Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study. Invest New Drugs. 2013 Oct;31(5):1283-93. doi: 10.1007/s10637-013-9962-7. Epub 2013 Apr 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nintedanib | Small molecule | 200 mg | Oral |
| Comparator | Sunitinib | Small molecule | 50 mg | Oral |