NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

Inclusion Criteria

• •Age ≥ 18 years
• •Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
• •Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin
• •ECOG Performance Status 0 - 2
• •Life expectancy of ≥ 12 weeks
• •Adequate baseline bone marrow, hepatic and renal function, defined as follows:
• •1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
• •2. Bilirubin ≤ 1.5 x ULN
• •3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
• •4. Serum creatinine \< 1.5 x ULN
• •Measurable or non-measurable disease according to MPM-modified RECIST criteria
• •Patients may have had prior therapy providing the following conditions are met:
• •1. Surgery: wash-out period of 14 days
• •2. Systemic and radiation anti-tumor therapy: wash-out period of 28 days
• •Patients must give written informed consent to participate in the study