GR015: Randomised 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

COMPANY IS INNOPHARMA S.R.L, ITALY0 sites45 target enrollmentStarted: TBDLast updated: May 6, 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. Prior treatment with no more than one sistemic 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.;
•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: wash-out period of 14 days;
•b. Systemic anti-tumor and radiation therapy: wash-out period of 28 days;
•9. Patients must give written informed consent to participate in the study;

•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 tampering compliance with the study protocol;
•9. Pregnancy or lactation.

Sponsor

COMPANY IS INNOPHARMA S.R.L, ITALY