patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic MedDRA version: 6.1 Level: PT Classification code 10035605
Conditions
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy
Outcome results
None listed