GR019: Randomized double-blind phase II study of NGRhTNFversus placebo as maintenance treatment in patients with advancedmalignant pleural mesothelioma (MPM) - NGR019

MOLMED0 sites137 target enrollmentStarted: August 7, 2012Last updated: September 9, 2024

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. Patients with non-progressive disease (i.e., complete response, partial response or stable disease) after six cycles of first-line, pemetrexed-based regimen administered for advanced or metastatic disease.
•4. ECOG Performance Status 0 - 1
•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: wash-out period of 14 days
•b. Radiation therapy: wash-out period of 28 days
•c. Chemotherapy: wash-out period of 21 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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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