GR015: Randomized double-blind phase III study of NGR-hTNF plus best investigator s choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM) - NGR015

MOLMED0 sites390 target enrollmentStarted: December 10, 2009Last updated: February 19, 2018

Conditions

Trial Snapshot

No summary available.

•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 < 1.5 x ULN 7.Measurable or non-measurable disease according to MPM-modified RECIST criteria 8.Patients may have had prior therapy providing the following conditions are met: a.Surgery and radiation therapy: wash-out period of 14 days b.Systemic anti-tumor therapy: wash-out period of 28 days 9.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

•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.

Sponsor

MOLMED