NCT00483093

Study of NGR-hTNF in Combination With Cisplatin in Solid Tumor

NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (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 document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).

Detailed description

This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned. Patients, with advanced or metastatic solid tumor not amenable of standard therapy will be enrolled.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	NGR-hTNF	iv q3W escalating dose NGR-hTNF up to 1.6 mcg/sqm
DRUG	Cisplatin	iv q3W 80 mg/sqm 30 minutes after NGR-hTNF infusion for a maximum of six cycles

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-06-01
• Completion: 2013-04-01
• First posted: 2007-06-06
• Last updated: 2014-05-30

Locations

2 sites across 1 country: Italy