A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Advanced Solid Tumors
Interventions
DRUG

NGR-hTNF

"Drug: NGR-hTNF~NGR-hTNF was administered every 3 weeks by a 1 hour intravenous iv infusion. NGR-hTNF in PBS was diluted in 0.9% NaCl, containing human serum albumin.~Step 1:~* starting dose: 0.2 μg/m2~* following doses: 0.4, 0.8 and 1.6 μg/m2.~* number of patients: 4 per dose level~Step 2:~* starting dose: 3.2 μg/m2~* following doses: 6.4 and 12.8 μg/m2~* number of patients: 3 per dose level~Step 3:~* starting dose: 19.2 μg/m2~* following doses: 28.8, 43.2 and 64.8 μg/m2~* number of patients: 3 per dose level~Step 4:~* starting dose: 86.2 μg/m2~* following doses: 114.6 and 152.4 μg/m2~* number of patients: 3 per dose level"

Trial Locations (1)

Unknown

Fondazione San Raffaele del Monte Tabor, Milan

Sponsors
All Listed Sponsors
lead

AGC Biologics S.p.A.

INDUSTRY