Advanced MPM patients with non-progressive disease after six cycles of a first-line, pemetrexed-based regimen MedDRA version: 9.1 Level: LLT Classification code 10035605
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. 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 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 F.1.3 Elderly (>=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 progression-free survival (PFS) in patients randomized to NGR-hTNF versus patients randomized to placebo;Secondary Objective: • To compare overall survival (OS) • To assess tumour response in the two treatment arms by MPM-modified RECIST criteria • To evaluate safety and toxicity profile related to NGR-hTNF • To assess changes in quality of life (QoL) in the two treatment arms;Primary end point(s): To compare progression-free survival (PFS) in patients randomized to NGR-hTNF versus patients randomized to placebo | — |
Countries
Germany, Italy
Outcome results
None listed