NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer
Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate
constitutional symptoms, the reversibility of these adverse events generally occurring only
during the infusion time; the absence of overlapping toxicities with chemotherapeutic
agents; the safety and preliminary antitumor activity observed in previous trial with
doxorubicin; and the objective response rate (RR) registered in a phase II trial in
previously treated ovarian cancer patients seems justified to evaluate in a randomized phase
II trial the efficacy of NGR-hTNF against a doxorubicin-based option in advanced ovarian
cancer patients progressing or recurrent after a standard platinum/taxane-based
chemotherapy.
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 6-8-12 weeks
No
Antonio Lambiase, MD
Study Director
MolMed S.p.A.
Italy: Ethics Committee
NGR018
NCT01358071
June 2011
February 2014
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