patient with neuroendocrine tumors MedDRA version: 21.0 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SANDOSTATINA - LAR 30 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI
Product Name: SANDOSTATINA
Product Code: OCTEOTRIDE
Pha
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
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 =/=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ¿ 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;Secondary Objective: 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. ;Primary end point(s): difference in the comparison between baseline pre-treatment and the six-month T-Reg and MDSC values;Timepoint(s) of evaluation of this end point: at time 0, after 15, 90 and 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate, safety and PFS;Timepoint(s) of evaluation of this end point: every 3 months | — |
Countries
Italy, United Kingdom
Contacts
Public ContactOncologia Addominale
Istituto Nazionale Tumori IRCCS Pascale
Outcome results
None listed