drugset / Trial / NCT00305084

Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors

NCT00305084

Phase 1 Completed 15 enrolled AGC Biologics S.p.A.
Non-randomizedSequentialOpen-labelTreatment

Summary

The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).

Timeline

Start
2006-02-28
Primary completion
2007-05-08
Completion
2007-05-08

Drugs

EvaluationDrugModalityDoseRoute
Subject NGR-hTNF Protein / enzyme biologic 0.2 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 0.4 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 0.8 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 1.6 ug/m2 Intravenous
Background Doxorubicin Other / unclassified 75 mg/m2 Intravenous

Indications