A Phase 1b, Open-Label, Dose-Finding Study to Evaluate the Safety of Tivozanib (AV-951) in Combination With Temsirolimus in Subjects With Metastatic Renal Cell Carcinoma

Phase 1 Completed 28 enrolled AVEO Pharmaceuticals, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety and tolerability of tivozanib (AV-951) and Torisel™ given in combination for renal cell cancer. The study will also assess the effects of the combination of tivozanib (AV-951) and Torisel™ on the tumor. Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus is an mTOR inhibitor which is approved for the treatment of advanced renal cell carcinoma.

Timeline

Start: 2007-11
Primary completion: 2010-11
Completion: 2011-02

Publications

Fishman MN, Srinivas S, Hauke RJ, Amato RJ, Esteves B, Cotreau MM, Strahs AL, Slichenmyer WJ, Bhargava P, Kabbinavar FF. Phase Ib study of tivozanib (AV-951) in combination with temsirolimus in patients with renal cell carcinoma. Eur J Cancer. 2013 Sep;49(13):2841-50. doi: 10.1016/j.ejca.2013.04.019. Epub 2013 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temsirolimus	Small molecule	15 mg	Intravenous
Subject	Temsirolimus	Small molecule	25 mg	Intravenous
Subject	Tivozanib	Small molecule	0.5 mg	Oral
Subject	Tivozanib	Small molecule	1 mg	Oral
Subject	Tivozanib	Small molecule	1.5 mg	Oral

A Phase 1b, Open-Label, Dose-Finding Study to Evaluate the Safety of Tivozanib (AV-951) in Combination With Temsirolimus in Subjects With Metastatic Renal Cell Carcinoma

Summary

Timeline

Publications

Drugs

Indications