Study of NGR-hTNF Administered at High Doses in Patient With Advanced or Metastatic Solid Tumour

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions
Solid Tumors
Interventions
DRUG

NGR-hTNF

"First cohort: iv q3W 60 mcg/sqm over 120 min\*~Second cohort: iv q3W 80 mcg/sqm over 120 min\*~Third cohort: iv q3W 100 mcg/sqm over 120 min\*~Fourth cohort: iv q3W 125 mcg/sqm over 120 min\*~Fifth cohort: iv q3W 150 mcg/sqm over 120 min\*~Sixth cohort: iv q3W 175 mcg/sqm over 120 min\*~Seventh cohort: iv q3W 200 mcg/sqm over 120 min\*~Eighth cohort: iv q3W 225 mcg/sqm over 120 min\*~Ninth cohort: iv q3w 250 mcg/sqm over 120 min\*~Tenth cohort: iv q3w 275 mcg/sqm over 120 min\*~Eleventh cohort: iv q3w 300 mcg/sqm over 120 min\*~Twelfth cohort: iv q3w 325 mcg/sqm over 120 min\*~\* If the first infusion is well-tolerated, the second infusion may be delivered over 90 minutes. If the 90-minute infusion is well tolerated, all subsequent infusions may be delivered over a 60-minute period."

Trial Locations (1)

20089

Istituto Clinico Humanitas, Rozzano

Sponsors
All Listed Sponsors
lead

AGC Biologics S.p.A.

INDUSTRY