E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patient with neuroendocrine tumors |
pazienti con tumore neuroendocrino |
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E.1.1.1 | Medical condition in easily understood language |
patient with neuroendocrine tumors |
pazienti con tumore neuroendocrino |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052399 |
E.1.2 | Term | Neuroendocrine tumour |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
¿ The primary objective of the project is to evaluate changes in immune-regulatory cells induced by OCT LAR from baseline to month 6. Therefore, we will observe the impact of OCTREOTIDE LAR on the immune response by studying T-Reg and MDSC and the immunoregulatory cell population in peripheral blood of patients with neuroendocrine tumors G1 / G2 treated with Octreotide LAR |
Valutare l¿impatto di OCTREOTIDE LAR sulla risposta immunitaria studiando T-Reg e MDSC e la popolazione cellulare immunoregolatoria nel sangue periferico di pazienti affetti da tumore neuroendocrino NET G1/G2 NET trattati con Octreotide LAR . |
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E.2.2 | Secondary objectives of the trial |
Objective response rate according to RECIST. Safety reporting. Progression-free survival (PFS), defined as the time (days) from start date of octreotide to date of first documented disease progression or death due to any cause, if death occurs before progression is documented.
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tasso di risposta obiettiva Tossicit¿ PFS |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
¿ Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient’s awareness and willingness to comply with the study requirements. ¿ Patients =18 years of age. ¿ Patients with histologically confirmed well and moderately differentiated Neuroendocrine Tumors with Ki67 =/< 20% (Ki67 must be quantified in percentage) and candidates for treatment with octreotide. ¿ ECOG performance status (PS) of 0-2. ¿ At least 28 days since prior the last radiation therapy or surgery. ¿ Estimated life expectancy of =12 weeks.
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- Consenso informato prima di iniziare qualsiasi procedura dello studio . - Età = a 18 anni. - Diagnosi istologica di Tumore Neuroendocrino ben o moderatamente differenziato G1/G2 ( Ki-67 inferiore al 20%) in trattamento con OCT. - ECOG performance status (PS) uguale a 0-2. - Almeno 28 giorni di wash out da qualsiasi altro trattamento - Aspettativa di vita superiore a 12 settimane
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E.4 | Principal exclusion criteria |
¿ Patients < 18 years of age. ¿ According to the current SmPC of the prescribed drug agent. ¿ Previuos treatment with octreotide. ¿ Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements. ¿ Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry. ¿ Patients who are treated with any medicinal product that contraindicates the use of the study drug, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications. ¿ Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential ¿ Patients with meningeal carcinomatosis ¿ Patients with known positive HIV status
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- Età inferiore ai 18 anni - Disturbi psichiatrici - Infezioni in atto sierologicamente e clinicamente diagnosticate - Trattamenti in corso che possano interferire sulla tollerabilità e sull’efficacia del farmaco in studio - Gravidanza o allattamento. |
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E.5 End points |
E.5.1 | Primary end point(s) |
difference in the comparison between baseline pre-treatment and the six-month T-Reg and MDSC values |
Differenza nel confronto tra il valore basale pre-trattamento e il valore a sei mesi di T-Reg e MDSC |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at time 0, after 15, 90 and 180 days |
al tempo 0, dopo 15, 90 e 180 giorni |
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E.5.2 | Secondary end point(s) |
Response rate, safety and PFS |
Tasso di risposta, tossicit¿ e PFS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
every 3 months |
ogni 3 mesi |
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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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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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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 |