E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient with metastatic melanoma (stage IV) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10025671 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. Studying the relationship between pharmacologic dose of esomeprazole and clinical response, in terms of objective responses, response duration, time to progression (TTP) 2. Biological objectives (principle trial): analisys of the changes of immunohistochemistry in the expression of V-APTasis and of the in vitro sensitivity to Cisplatinum before and after treatment with esomeprazole. |
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E.2.2 | Secondary objectives of the trial |
1. Evaluating the relationship between the dose of trial drug and the onset of side effects (global therapeutic index) 2. Assessing the entity of tumor necrosis evalued as immunohistochemical analisys on a lesion biopsied after treatment compared to a lesion biopsied before treatment with esomeprazole. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. age >18 and <75 years 2. Histo- and/or cytologically confirmed skin melanoma 3. Advanced non-ocular melanoma, non-operable (stage IIIC, non-treatable with hypotermic-antiblastic perfusion or recurrent after such, stage IV), in presence of multiple biopsable subcutaneous or lymphonodal lesions 4. Performance status 0-1 (ECOG) 5. Life expectancy more or equal to 3 months 6. Measurable and/or evaluable sites of metastasis, confirmed by imaging (simple X-rays, echography of soft tissue, CAT and NMR ヨ diameter at least 1 cm) 7. A previous chemioterapic treatment containing decarbazine or fotemustine and/or immuno/biochemiotherapy with IFN/IL-2 and/or a vaccine are allowed (anyhow, a wash period of at least 4 weeks is requested) 8. Normal haemochromocytometric exam: neutrophiles >1500/microlitres and platelet count >30.000 microlitres, liver functionality (ALT, AST levels and Alkaline phosphatase less or equal to 2.5x upper normal limits, creatinemia within normal range, and particulary cratinin clearance >50 mL/min or creatinemia lesso or equal to 1.5x UNL) 9. Informed Consent written according to Local ethical Committee requests 10. Patient accessibility to treatment and follow-up 11. Complete work-up within 4 weeks before treatment start |
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E.4 | Principal exclusion criteria |
1. Previous tumors, diagnosed in last 5 years, with the exception of treated skin carcinomas or in situ, properly treated cervix carcinomas. 2. Pregnancy and breast-feeding. Women in post-menopause must present amenorrea since 12 months at least. Sexually active males and females (in fertile age) who do not want to use contraception during the trial. 3. Recent major surgery interventions (within 28 days before study treatment) 4. Planned radiotherapy for melanoma metastasis 5. Clinical or radiological evidence of metastasis in Central Nervous System (CNS) 6. Positive clinical history for other important pathologies: a. evidence of haemorrhagic diathesis or coagulopathy; b. non-controlled hypertension c. congestitial cardiac insufficiency (NYHA stage more or equal to 2), previous myocardial infarction or cerebrovascular events within 6 months, unstable angina, severe heart arythmia requiring specific treatment; d. History of significant neurological or psychiatric pathologies which would compromise the comprehension and the issuing of the informed consent; e. infection requiring an antibiotic therapy by EV and tuberculosis in treatment at the moment of trial start; f. active peptic ulcer, unstable diabetes mellitus, cyrrosis and other significant pathologies |
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E.5 End points |
E.5.1 | Primary end point(s) |
In case of positive study outcome, expected advantages for treated and future patients are identified not only in a better clinical response, but also in a better tolerability of the patient to chemiotherapic treatment. Moreover, the study drugメs way of use does not require to modify the habitual use of chemiotherapic drugs. |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
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.8.5 | 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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |