NCT00419328

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

NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AGC Biologics S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.

Detailed description

This is a modified phase I Single arm, open, non randomized trial of NGR-hTNF in advanced solid tumors for the definition of an optimal biological

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-01-08
• Last updated: 2022-07-21

Locations

1 site across 1 country: Italy