Title

The MetNET-2 Trial
Safety of Lanreotide 120 mg ATG in Combination With Metformin in Patients With Progressive Advanced Well-differentiated Gastro-intestinal (GI) or Lung Carcinoids: A Pilot, One-arm, Open-label, Prospective Study: the MetNET-2 Trial
  • Phase

    Early Phase 1
  • Study Type

    Interventional
  • Status

    Active, not recruiting
  • Study Participants

    20
This is a Pilot, One-arm, Open-label, Prospective Study to evaluate Safety of Lanreotide 120 mg ATG in combination with Metformin in patients with advanced progressive GI or lung carcinoids.

The patient population will include patients with a histologically documented diagnosis of Well differentiated NET, G1-G2 according to the last WHO Classification criteria for GI and lung NET carcinoids.
This study is strategically positioned in the medical treatment safety and efficacy context, that is Lanreotide can be safely and effectively used in combination with other agents, like Metformin.

Aim of this study is to verify the safety of a concomitant administration of Lanreotide 120 mg ATG with Metformin in advanced, progressing gastro-intestinal or lung carcinoids patients, by accurately monitor patients from a tolerability point of view during all study long.
Study Started
Apr 30
2016
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Jun 07
2021

Drug Lanreotide and Metformin

Lanreotide and Metformin

  • Other names: Ipstyl and Metformin

Lanreotide and Metformin Experimental

Dose and Treatment Regimen: LANREOTIDE ATG 120 mg/28 days (equivalent to 1 cycle), deep subcutaneous injection (SC) in combination with METFORMIN 2550 mg daily (maximum dose), oral administration (OS). Metformin starting dose 850 mg/day to be increased up to 1700 mg/day at day 14, 2550 mg/day at day 28, (maximum dose), if well tolerated.

Criteria

Inclusion Criteria:

Adult patients (male or female, age > 18 years)
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.
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
Tumor tissue available for analysis
Measurable disease and disease progression in the 6 months before study inclusion (according to RECIST vs 1.1), documented and appropriate imaging
Patient who has received prior treatment with surgery or chemotherapy or somatostatin analogues or m-TOR inhibitors or other systemic antineoplastic/target therapies
Functioning or non-functioning NETs
Type-2 Diabetic or normoglycaemic patient
Documented Octreoscan/PET Ga68 uptake/IHC stain of SSTR2 receptor, within 6 months before study entry
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
ECOG performance status ≤ 2
Life expectancy > 12 months
Written informed consent
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.
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.

Exclusion Criteria

Surgery performed within 28 days prior to the beginning of study treatment
Brain metastasis or spinal cord compression
Type-1 Diabetes
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
Uncontrolled high blood pressure, atrial fibrillation
Cardio-vascular, lung, kidney or hepatic disorders not treated/controlled
Cirrhosis, acute hepatitis or chronic active hepatitis
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
Active or uncontrolled severe infections
Patients with a condition of metabolic acidosis, acute or chronic, including ketoacitosi
History of POTUS (alcohol abuse), or habitual intake of alcohol (≥ 3 glasses of alcoholic drinks / day) sufficient to cause hepatotoxicity
Severe states of dehydration
Prolonged fasting
History of immunosuppression, including positive HIV test
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
Serious neurological or psychiatric disorders
Pregnancy or lactation
Patients that do not use appropriate methods of contraception as specified in the inclusion criteria
No Results Posted