Lanreotide for Well-differentiated gastro-intestinal neuroendocrine tumour (carcinoid) | Well-differentiated pulmonary (lung) carcinoid

Inclusion criteria

• {"criterion_text":"- Adult patients (male or female, age > 18 years)\n- Basal blood tests: - Counts of neutrophils in absolute value> 1.5 x 103 / L - Platelet count> 100 x 103 / L - Hemoglobin> 9 g/dl - Total Bilirubin <1.5 times the upper limit of normal - AST, ALT <2.5 times the upper limit of normal - Alkaline phosphatase <2.5 times the upper limit of normal - Values of serum creatinine <1.5 mg / dl. - CCr ≥ 60 mL / min\n- ECOG performance status ≤ 2\n- Life expectancy > 12 months\n- Written informed consent\n- Female subjects of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for at least 60 days after participation in the study. Acceptable methods of contraception include double barrier method [i.e. condom and occlusive cap (diaphragm or cervical/vault caps)] spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.\n- Male subjects with female partners of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 60 days after participation in the study\n- Patient with advanced disease, not resectable. The evaluation of unresectable disease will be performed by surgeon of multidisciplinary Milan ENETS Center of Excellence tumour board of Fondazione IRCCS Istituto Nazionale dei Tumori Milano.\n- Patients with a histologically documented diagnosis of advanced well differentiated (G1 and G2) GI or lung carcinoids, defined according to the last WHO Classification criteria for NET\n- Tumor tissue available for analysis\n- Measurable disease and disease progression in the 6 months before study inclusion (according to RECIST vs 1.1), documented and appropriate imaging\n- Patient who has received prior treatment with surgery or chemotherapy or somatostatin analogues or m-TOR inhibitors or other systemic antineoplastic/target therapies\n- Functioning or non-functioning NETs\n- Type-2 Diabetic or normoglycaemic patient\n- Documented Octreoscan/PET Ga uptake/IHC stain of SSTR2 receptor, within 6 months before study entry"}

Exclusion criteria

• {"criterion_text":"- Surgery performed within 28 days prior to the beginning of study treatment\n- Patients with a condition of metabolic acidosis, acute or chronic, including ketoacitosi\n- History of POTUS (alcohol abuse), or habitual intake of alcohol (≥ 3 glasses of alcoholic drinks / day) sufficient to cause hepatotoxicity\n- Severe states of dehydration\n- Prolonged fasting\n- History of immunosuppression, including positive HIV test\n- Previous or concomitant oncological pathology, except: basal cell skin cancer, in situ, as long as every other cancer patient disease-free for at least 5 years\n- Serious neurological or psychiatric disorders\n- Pregnancy or lactation\n- Patients that do not use appropriate methods of contraception as specified in the inclusion criteria\n- Brain metastasis or spinal cord compression\n- Type-1 Diabetes\n- Clinically significant cardiovascular disease, such as cardiovascular accidents occurred in less than 6 months, unstable angina, congestive heart failure grade greater than or equal to II (according to the classification of the New York Heart Association NYHA) series cardiac arrhythmias that require treatment\n- Uncontrolled high blood pressure, atrial fibrillation\n- Cardio-vascular, lung, kidney or hepatic disorders not treated/controlled\n- Cirrhosis, acute hepatitis or chronic active hepatitis\n- Metabolic disorders, clinical examination or laboratory investigations which contraindicate the use of drugs to study, or patients at high risk of complications from the treatment\n- Active or uncontrolled severe infections"}

Primary endpoints

• {"endpoint_text":"- To evaluate the incidence of SAEs and AEs, physical examination output, laboratory tests results, and cardiologic assessment, during treatment study period.","definition_or_measurement_approach":"Incidence (number) of adverse events (AEs) and serious adverse events (SAEs), together with findings from physical examinations, laboratory test results and cardiologic assessments performed during the treatment period."}

Secondary endpoints

• {"endpoint_text":"- To evaluate the efficacy of Lanreotide ATG 120 mg in combination with Metformin on the time to progression (TTP), defined as the time from first study drugs administration (Lanreotide 120 mg plus Metformin) to the first radiological or clinical or biochemical progression or tumor-related death, according to RECIST criteria vs 1.1.","definition_or_measurement_approach":"TTP defined as time from first administration of study drugs to first radiological, clinical or biochemical progression or tumor-related death, assessed according to RECIST v1.1."}
• {"endpoint_text":"- To evaluate the efficacy of Lanreotide ATG 120 mg in combination with Metformin on symptomatic response.","definition_or_measurement_approach":"Symptomatic response as assessed by clinical evaluation of patient symptoms; specific measurement approach not detailed in provided text."}

Italy

Earliest CTIS Part Ii Submission Date

26-03-2024

Latest Decision Or Authorization Date

03-06-2024

Processing Time Days

69

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Fondazione IRCCS Istituto Nazionale Dei Tumori

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy