The MetNET-2 Trial

NCT02823691 | Unknown Early Phase 1

• 1 other identifier: NationalCIMilan
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroendocrine Tumors

Keywords

NETs

Outcome Measures

Primary Outcomes (1)

• incidence of SAEs and AEs

  1 year

Secondary Outcomes (3)

• time to progression (TTP) to Lanreotide ATG 120 mg in combination with Metformin

  3 years

• symptomatic responses to Lanreotide ATG 120 mg in combination with Metformin in symptomatic patients

  1 year

• biochemical responses to Lanreotide ATG 120 mg in combination with Metformin

  1 year

Study Arms (1)

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.

Drug: Lanreotide and Metformin

Interventions

Lanreotide and Metformin DRUG

Lanreotide and Metformin

Also known as: Ipstyl and Metformin

Lanreotide and Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

NationalCIMilan

Milan, 20133, Italy

Location

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MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lanreotide; Metformin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sara Pusceddu, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: July 6, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

IT (1)