E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA |
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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 | 10059518 |
E.1.2 | Term | Pleural mesothelioma malignant |
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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 assess the rate of objective clinical responses (CR + PR) |
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E.2.2 | Secondary objectives of the trial |
1) To estimate disease control rate (proportion of patients with best response of CR+PR+SD) 2) To assess the progression-free survival in treated patients 3) To evaluate qualitative and quantitative changes in cellular and humoral immune responses 4) To define toxicity profile |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: Lo studio prevede studi di ricerca traslazionale di laboratorio (studi immunofenotipici della sottopopolazioni linfocitarie) che saranno effettuati c/o Lab. interno della UOC Immunoterapia Oncologica
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E.3 | Principal inclusion criteria |
 Histologically or cytologically confirmed malignant mesothelioma  Have received only one prior systemic chemotherapy regimen for advanced mesothelioma  Measurable disease, defined at least 1 unidimemensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (RECIST criteria).  Disease not amenable to curative surgery  No known brain metastasis  Age 18 and over  Performance status 0-2  Life expectancy > 12 weeks  Adequate hematologic, hepatic and renal function o Platelet count > 100000/mm3 o Absolute granulocyte count > 1500/mm3 o Hemoglobin > 9 g/dL o Bilirubin total < 2 x ULN (Upper limited normal) o AST and ALT < 2.5 x ULN (< 5 x ULN if documented liver metastasis are present) o Creatinine level < 2mg/dl or creatinine clearance > 50 mL/min  Not pregnant or nursing  Fertile patients must use effective contraception  Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution |
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E.4 | Principal exclusion criteria |
 History of or significant evidence of risk of chronic inflammatory or autoimmune disease (eg Addisons disease, multiple sclerosis, Graves disease, Hashimotos thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erytematotosus, hypophysitis, pituitary disorders, etc.)  History of diverticulitis  History of hepatitis B or C  Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more  History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent  Uncontrolled active infections  Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study  Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents  History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the rate of objective clinical responses Objective tumor response, defined as a confirmed complete response (CR) or partial response (PR), will be assessed using the RECIST criteria or modified RECIST criteria for assessment of response in malignant pleural mesothelioma. |
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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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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dall'arruolamento del primo soggetto fino all'ultima visita dell'ultimo soggetto |
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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 | |
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 |