Neuroendocrine tumours MedDRA version: 14.1 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: IPSTYL*SC SIR 90MG
Pharmaceutical Form: Solution for injection
Current Sponsor code: LAN HD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Sponsors
UNIVERSITA' DI GENOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects of both gender, aged =18 years AND = 75 years 2) patients with histological diagnosis of WD NETs, defined according to the recent WHO classification for gastroentero pancreatic (WHO 2010), bronchial and thymic NET(WHO 2004) or with hepatic metastases documented through a bioptic exam and Occult Primary tumor; patient with or without carcinoid syndrome could be enrolled; 3) Patients on treatment with standard dosages of octreotide LAR (30 mg/28 days) or lanreotide Autogel (120 mg/28 days) in the 6 months before enrollment; 4) Patients with tumor/biochemical/ symptomatic disease progression 5) Urine negative pregnancy test for women of childbearing age. Female subjects of childbearing potential must be using an appropriate method of contraception like double-barrier contraception , oral estroprogestinic contraceptive or an intrauterine device (IUD). Patient must be willing to continue using it throughout the entire study period, until two month after the study end; if the patient is a man, if the partner is a childbearing potential female, he should agree to using appropriate method of contraception; Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. patients initially not responsive to SSA 2. patient naive to any treatment to SSA analogues 3. stable disease on treatment with SSA at standard dosages; 4. previous surgical treatment for NET in the 4 weeks before enrollment or planned during the study; 5. symptomatic colelitiasis 6. unstable angina, supported ventricular tachycardia, ventricular fibrillation, myocardial infarction in three months before enrollment; 7. hepatic disease here included cirrhosis, chronic or active hepatitis, permanent increase of AST, ALT, alkaline phosphatase 2xULN (upper limit normal) or increase of AST, ALT, alkaline phosphatase 4xULN (upper limit normal) in patients with hepatic metastases, total bilirubin 1.5xULN or creatinine 1.5xULN; 8. Specific previous antitumor treatment, here included, chemotherapy, chemoembolization, radiotherapy, PRRT or interferon in the 6 months before enrollment or planned during the study (based in investigator judgment) 9. Previous neoplastic disease (excepted basal cell carcinoma, cervical carcinoma in situ or uterine cancer, thyroid microcarcinoma or thyroid and prostate carcinoma surgically eradicated). Patients with carcinoma diagnosis can be enrolled in the study only if treated with a curative intent and free from disease from at least 5 years; 10. Decompensated diabetes mellitus (HbA1c> 8%); 11. Pregnant or breast-feeding women; Female subjects of childbearing potential not using an appropriate anticonceptive method 12. Hypersensitivity to lanreotide 13. Presence of adverse events (grade>1 according to NCI CTCAE (Versione 3.0) criteria) related to SSA treatment at inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to evaluate the safety of lanreotide 90 mg in double dose (lanreotide 180 mg) every 28 days in patients affected by well differentiated neuroendocrine tumours (WD NETs) with disease progression during standard treatment with SSA (lanreotide 120mg ooctreotide 30mg every 28 days).;Secondary Objective: Secondary study Objectives are efficacy evaluations through tumor, clinical and laboratory parameters.;Primary end point(s): The primary endpoint for safety evaluation, is the patient proportion that has at least a serious adverse event during treatment with lanreotide.;Timepoint(s) of evaluation of this end point: At each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary safety end points: 1. Proportion of patient with at least an adverse event; 2. Proportion of patient with at least an adverse event related to study drug; 3. Proportion of patient with at least an adverse event grade 3 and 4 according to NCI CTCAE versione 3 classification; 4. Proportion of patient with at least an adverse event grade 3 and 4 according to NCI CTCAE versione 3 classification related to study drug; Efficacy secondary End point: 5. Time to progression (TTP) from first study drug assumption until disease progression or death due to the study disease; 6. Changes in lesions diameter after 6 and 12 months of study treatment from basal; 7. Proportion of patient with an improvement in disease symptoms (diarrea e/o flushing) after 6 and 12 months of study treatment from basal (in patients with symptomatic NET); 8. Changes in percentage in the mean diarrea and/or flushing episodes numbers after 6 and 12 months of study treatment from basal (in patients with symptomatic NET); 9. Percentage of patients with a globally satisfying symptoms improvement based on Likert scale after 6 and 12 months of study treatment (in patients with symptomatic NET); 10. Changes in 5-HIAA levels after 6 and 12 months of study treatment from basal (in patients with basal levels increased); 11. Changes in chromogranina A levels after 6 and 12 months of study treatment from basal (in patients with basal levels increased).;Timepoint(s) of evaluation of this end point: See Paragraph ''Secondary end point'' for details | — |
Countries
Italy
Contacts
Public ContactReparto di Endocrinologia
DiMI di Genova
Outcome results
None listed