AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib

Summary

This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.

Timeline

Start

2007-05

Primary completion

2010-04

Completion

2014-06

Outcome

Missed primary endpoint

paper CONCLUSIONS: In patients with mRCC, AMG 386 plus sorafenib was tolerable but did not significantly improve PFS compared with placebo plus sorafenib. PMID 22692704 ↗

Publications

• Rini B, Szczylik C, Tannir NM, Koralewski P, Tomczak P, Deptala A, Dirix LY, Fishman M, Ramlau R, Ravaud A, Rogowski W, Kracht K, Sun YN, Bass MB, Puhlmann M, Escudier B. AMG 386 in combination with sorafenib in patients with metastatic clear cell carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2 study. Cancer. 2012 Dec 15;118(24):6152-61. doi: 10.1002/cncr.27632. Epub 2012 Jun 12.

Drugs

Indications