Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma (NGR010)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- • Antitumor activity defined as progression free survival (PFS) [ Time Frame: during the study ] [ Designated as safety issue: No ]
- • Tumor Growth Control Rate (TGCR) according to RECIST criteria • Overall survival (OS) [ Time Frame: during the study ] [ Designated as safety issue: No ]
- • Experimental Imaging Study (DCE-MRI) [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
- • Pharmacokinetics in patients treated with weekly schedule [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
- •Safety [ Time Frame: During the treatment and during the follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
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.
|Istituto Clinico Humanitas|
|Rozzano, Milan, Italy|
|Istituto Europeo Oncologico|
|Istituto Nazionale dei Tumori|
|Fondazione San Raffaele del Monte Tabor|
|Study Director:||Antonio Lambiase, MD||MolMed S.p.A.|