NGR016: Randomized Phase II Study Evaluating Two Doses of NGR-hTNF Administered Either as Single Agent or in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma (STS)
Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate
constitutional symptoms when given either every three weeks or weekly both at low (0.8
µg/m^2) and high dose (45 µg/m^2); the reversibility of these adverse events generally
occurring only during the infusion time; the absence of overlapping toxicities with
chemotherapeutic agents; and the safety and preliminary antitumor activity observed in phase
Ib trial with doxorubicin, seems justified to evaluate in a randomized 4-arm phase II trial
the preliminary antitumor activity of two doses of NGR-hTNF (0.8 µg/m^2 and 45 µg/m^2)
administered weekly either alone or in combination with a standard dose of doxorubicin (60
mg/m^2 every three weeks).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Defined as the time from the date of randomization until disease progression, or death
every 6-12 weeks
No
Antonio Lambiase, MD
Study Director
MolMed S.p.A.
Italy: Ethics Committee
NGR016
NCT00484341
October 2010
December 2013
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