drugset / Trial / NCT00484341

Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas.

NCT00484341

Phase 2 Completed 69 enrolled AGC Biologics S.p.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of the trial is to document the preliminary antitumor activity of two doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally advanced or metastatic soft-tissue sarcoma (STS) patients untreated or previously treated with one or more prior systemic regimen.

Timeline

Start
2010-10
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 0.8 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 45 ug/m2 Intravenous

Indications