drugset
drugset / Trial / NCT00878111

Study of NGR-hTNF Administered at High Doses in Patient With Advanced or Metastatic Solid Tumour

NCT00878111 ↗

Phase 1 Completed 48 enrolled AGC Biologics S.p.A.
NaSingle-groupOpen-labelTreatment

Summary

The main objective of the trial is to document the safety and antivascular effect of escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by advanced or metastatic solid tumors not amenable of standard therapies. Safety will be established by clinical and laboratory assessment according to NCI-CTCAE criteria (version 4.02).

Timeline

Start
2009-04
Primary completion
2017-02
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject NGR-hTNF Protein / enzyme biologic 60 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 80 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 100 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 125 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 150 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 175 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 200 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 225 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 250 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 275 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 300 ug/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 325 ug/m2 Intravenous

Indications

cancer