Patients with advanced malignant pleural mesothelioma (MPM)previously treated with pemetrexed MedDRA version: 12.1 Level: LLT Classification code 10035605 Term: Pleural mesothelioma malignant advanced
Conditions
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age ≥ 18 years 2.Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown 3.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 4.ECOG Performance Status 0 - 2 5.Life expectancy of ≥ 12 weeks 6.Adequate baseline bone marrow, hepatic and renal function, defined as follows: a.Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL b.Bilirubin ≤ 1.5 x ULN c.AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis d.Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients must not receive any other investigational agents while on study 2.Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication 3.Uncontrolled hypertension 4.QTc interval (congenital or acquired) > 450 ms 5.History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke) 6.Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol 7.Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients 8.Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol 9.Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival (OS) in patients randomized to NGR-hTNF plus BIC versus patients randomized to placebo plus BIC;Secondary Objective: To compare progression-free survival (PFS) To compare disease control rate (DCR, defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified RECIST criteria) To compare duration of disease control To evaluate safety and toxicity profile related to NGR-hTNF To assess changes in quality of life (QoL) in the two treatment arms To evaluate medical care utilization in the two treatment arms;Primary end point(s): To compare overall survival (OS) in patients randomized to NGR-hTNF plus BIC versus patients randomized to placebo plus BIC | — |
Countries
Austria, Belgium, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed