NCT00484276

Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma

NGR010: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Previously Treated With no More Than One Systemic Therapeutic Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (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 progression free survival (PFS) in advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Detailed description

This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen , that will be conducted using Simon's two-stage design method.

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	NGR-hTNF	iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Timeline

• Start date: 2007-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2007-06-08
• Last updated: 2019-01-16

Locations

4 sites across 1 country: Italy