GR010: A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen - NGR010

• Conditions: patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic; MedDRA version: 6.1Level: PTClassification code 10035605

• Registration Number: EUCTR2006-005993-39-IT
• Lead Sponsor: MOLMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 29 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?Patients >=18 years affected by malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen ?Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatous, mixed ?Prior intrapleural cytotoxic agents including bleomycin not considered systemic chemotherapy ?ECOG Performance status 0 ? 2 ?Adequate baseline bone marrow, hepatic and renal function, defined as follows: -Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L -Bilirubin < 1.5 x ULN -AST and/or ALT < 2.5 x ULN in absence of liver metastasis -AST and/or ALT < 5 x ULN in presence of liver metastasis -Serum creatinine < 1.5 x ULN ?Absence of any conditions in which hypervoleamia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference ?Technical data sheet human albumin? specifically used in Pharmacy Department for NGR-hTNF dilution) ?Patients may have had prior therapy providing the following conditions are met: -Chemotherapy and radiotherapy: wash-out period of 28 days -Surgery: wash-out period of 14 days ?Normal cardiac function and absence of uncontrolled hypertension ?Patients must give written informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Concurrent anticancer therapy ?Patients may not receive any other investigational agents while on study ?Clinical signs of CNS involvement ?Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol ?Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients ?Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol ?Pregnancy or lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Antitumor activity defined as progression free survival (PFS);Secondary Objective: Tumor Growth Control Rate (TGCR) according to RECIST criteria;Overall survival (OS); Circulating Endothelial Cells (CECs);Experimental Imaging Study (DCE-MRI);Safety;Primary end point(s): Antitumor activity defined as progression free survival (PFS)