Phase 2 Study of Panzem® NCD Alone and Combined With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma

Phase 2 Completed 82 enrolled CASI pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic renal cell carcinoma progressing on Sunitinib Malate.

Timeline

Start: 2007-02
Primary completion: 2008-12
Completion: 2009-10

Outcome

Missed primary endpoint

paper 2ME2 NCD had minimal anti-tumor activity, with no observed objective responses. PMID 21174224 ↗

Publications

Results Bruce JY, Eickhoff J, Pili R, Logan T, Carducci M, Arnott J, Treston A, Wilding G, Liu G. A phase II study of 2-methoxyestradiol nanocrystal colloidal dispersion alone and in combination with sunitinib malate in patients with metastatic renal cell carcinoma progressing on sunitinib malate. Invest New Drugs. 2012 Apr;30(2):794-802. doi: 10.1007/s10637-010-9618-9. Epub 2010 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	2-methoxyestradiol	Small molecule	1500 mg	—
Subject	Sunitinib	Small molecule	—	Oral