48
Participants
Start Date
April 30, 2009
Primary Completion Date
February 28, 2017
Study Completion Date
February 28, 2017
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."
Istituto Clinico Humanitas, Rozzano
Lead Sponsor
AGC Biologics S.p.A.
INDUSTRY