E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced MPM patients with non-progressive disease after six cycles of a first-line, pemetrexed-based regimen |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035605 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare progression-free survival (PFS) in patients randomized to NGR-hTNF versus patients randomized to placebo |
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E.2.2 | Secondary objectives of the trial |
• 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare progression-free survival (PFS) in patients randomized to NGR-hTNF versus patients randomized to placebo |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Per conclusione dello studio si intende la data della visita di chiususra dell`ultimo centro, in quanto solo con la visita di chiusura tutti i dati saranno stati validati e i documenti dello studio riverificati |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |