drugset / Trial / NCT01358071

Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer

NCT01358071

Phase 2 Completed 119 enrolled AGC Biologics S.p.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone

Timeline

Start
2011-06
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject 50 mg/m² iv every 4 weeks until confirmed evidence of disease progression Unknown 50 mg/m2 Intravenous
Subject 60 mg/m² iv every 3 weeks for a maximum of 8 cycles Unknown 60 mg/m2 Intravenous
Subject NGR-hTNF Protein / enzyme biologic 0.8 ug/m2 Intravenous

Indications