drugset

drugset / Trial / NCT00785226

RDEA119 and Sorafenib Combination Dose Escalation Study

NCT00785226 ↗

Phase 1/2 Completed 62 enrolled Bayer

NaSingle-groupOpen-labelTreatment

Summary

Phase 1/2 dose escalation study to investigate the combination of RDEA119 and sorafenib in advanced cancer patients.

Timeline

Start: 2008-11
Primary completion: 2012-04
Completion: 2012-04

Publications

Results Adjei AA, Richards DA, El-Khoueiry A, Braiteh F, Becerra CH, Stephenson JJ Jr, Hezel AF, Sherman M, Garbo L, Leffingwell DP, Iverson C, Miner JN, Shen Z, Yeh LT, Gunawan S, Wilson DM, Manhard KJ, Rajagopalan P, Krissel H, Clendeninn NJ. A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer. Clin Cancer Res. 2016 May 15;22(10):2368-76. doi: 10.1158/1078-0432.CCR-15-1681. Epub 2015 Dec 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Refametinib	Small molecule	5 mg	Oral
Subject	Refametinib	Small molecule	50 mg	Oral
Subject	Sorafenib	Small molecule	200 mg	—
Subject	Sorafenib	Small molecule	400 mg	—

Indications

No indication recorded.