A Dose-Escalation Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer

Phase 1 Completed 67 enrolled CASI pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

A dose-escalation trial designed to assess the safety and tolerability of treatment with ENMD-2076 administered orally over a range of doses in patients with advanced cancer that is refractory to current treatment or for which no curative therapy exists.

Timeline

Start: 2008-04
Primary completion: 2010-12
Completion: 2012-06

Publications

Results Diamond JR, Bastos BR, Hansen RJ, Gustafson DL, Eckhardt SG, Kwak EL, Pandya SS, Fletcher GC, Pitts TM, Kulikowski GN, Morrow M, Arnott J, Bray MR, Sidor C, Messersmith W, Shapiro GI. Phase I safety, pharmacokinetic, and pharmacodynamic study of ENMD-2076, a novel angiogenic and Aurora kinase inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2011 Feb 15;17(4):849-60. doi: 10.1158/1078-0432.CCR-10-2144. Epub 2010 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ENMD-2076	Small molecule	60 mg/m2	Oral
Subject	ENMD-2076	Small molecule	80 mg/m2	Oral
Subject	ENMD-2076	Small molecule	120 mg/m2	Oral
Subject	ENMD-2076	Small molecule	160 mg/m2	Oral
Subject	ENMD-2076	Small molecule	200 mg/m2	Oral

Indications

No indication recorded.