Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas.

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Metastatic Adult Soft Tissue Sarcoma
Interventions
DRUG

low-dose NGR-hTNF

NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs

DRUG

high-dose NGR-hTNF

NGR-hTNF: 45 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs

DRUG

Doxorubicin

Doxorubicin: 60 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion) on day 1 every 3 weeks for a maximum of 6 cycles or until cumulative dose of 550 mg/m²

Trial Locations (7)

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan

27100

IRCCS Policlinico S. Matteo, Pavia

40136

Istituto Ortopedico Rizzoli, Bologna

69373

Centre Leon Berard, Lyon

94805

Institut de Cancérologie Gustave Roussy, Villejuif

00128

Università Campus Bio-Medico, Rome

BA11 3

Clatterbridge Centre for Oncology, Bebington

Sponsors
All Listed Sponsors
lead

AGC Biologics S.p.A.

INDUSTRY