NCT01358071

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

NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: AGC Biologics S.p.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	NGR-hTNF	NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion weekly or every 3 or 4 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs
DRUG	Pegylated liposomal doxorubicin	50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
DRUG	Doxorubicin	60 mg/m² iv every 3 weeks for a maximum of 8 cycles

Timeline

• Start date: 2011-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2011-05-23
• Last updated: 2018-09-27

Locations

8 sites across 2 countries: Italy, United Kingdom