A Study of LY2510924 and Sunitinib in Patients With Metastatic Renal Cell Carcinoma

Phase 2 Terminated 110 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the progression free survival of LY2510924 plus sunitinib therapy versus sunitinib in the first-line setting for patients with metastatic clear-cell renal cell carcinoma.

Timeline

Start: 2011-08
Primary completion: 2014-09
Completion: 2017-02

Outcome

Missed primary endpoint

Stopped: “Study Terminated due to Insufficient Efficacy”

registry analysis (superiority test); LY2510924 + Sunitinib vs Sunitinib; p = 0.4318; Hazard Ratio (HR) 1.2149 (95% CI 0.7462 to 1.9779); Log Rank NCT01391130 ↗

paper The addition of LY to SUN in the first-line treatment of metastatic RCC was well tolerated, but did not improve the PFS or overall survival (OS) vs. SUN alone. PMID 27154357 ↗

Publications

Hainsworth JD, Reeves JA, Mace JR, Crane EJ, Hamid O, Stille JR, Flynt A, Roberson S, Polzer J, Arrowsmith ER. A Randomized, Open-Label Phase 2 Study of the CXCR4 Inhibitor LY2510924 in Combination with Sunitinib Versus Sunitinib Alone in Patients with Metastatic Renal Cell Carcinoma (RCC). Target Oncol. 2016 Oct;11(5):643-653. doi: 10.1007/s11523-016-0434-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY2510924	Peptide	20 mg	Subcutaneous
Subject	Sunitinib	Small molecule	50 mg	Oral