Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma

Phase 1/2 Terminated 16 enrolled Celgene Corporation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.

Timeline

Start: 2009-09-01
Primary completion: 2011-10-01
Completion: 2011-10-01

Publications

Results Rini B, Redman B, Garcia JA, Burris HA 3rd, Li S, Fandi A, Beck R, Jungnelius U, Infante JR. A phase I/II study of lenalidomide in combination with sunitinib in patients with advanced or metastatic renal cell carcinoma. Ann Oncol. 2014 Sep;25(9):1794-1799. doi: 10.1093/annonc/mdu212. Epub 2014 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenalidomide	Other / unclassified	10 mg	Oral
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Sunitinib	Small molecule	37.5 mg	Oral

Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma

Summary

Timeline

Publications

Drugs

Indications