NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

Phase 2 Completed 24 enrolled AGC Biologics S.p.A.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments

Timeline

Start: 2007-12
Primary completion: 2010-12
Completion: 2013-05

Publications

Results Mammoliti S, Andretta V, Bennicelli E, Caprioni F, Comandini D, Fornarini G, Guglielmi A, Pessino A, Sciallero S, Sobrero AF, Mazzola G, Lambiase A, Bordignon C. Two doses of NGR-hTNF in combination with capecitabine plus oxaliplatin in colorectal cancer patients failing standard therapies. Ann Oncol. 2011 Apr;22(4):973-978. doi: 10.1093/annonc/mdq436. Epub 2010 Sep 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NGR-hTNF	Protein / enzyme biologic	0.8 ug/m2	Intravenous
Subject	NGR-hTNF	Protein / enzyme biologic	45 ug/m2	Intravenous
Background	Capecitabine	Small molecule	825 mg/m2	Oral
Background	Oxaliplatin	Small molecule	100 mg/m2	Intravenous

NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

Summary

Timeline

Publications

Drugs

Indications