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The MetNET-2 Trial

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02823691
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
68
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lanreotide and Metformin
 Early Phase 1

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lanreotide and Metformin

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
Lanreotide and Metformin
Other Names:
  • Ipstyl and Metformin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. incidence of SAEs and AEs [1 year]

    Secondary Outcome Measures

    1. time to progression (TTP) to Lanreotide ATG 120 mg in combination with Metformin [3 years]

      This is a pilot study. This endpoints should be considered an exploratory evaluation

    2. symptomatic responses to Lanreotide ATG 120 mg in combination with Metformin in symptomatic patients [1 year]

      Answers will be based on a 5 point Likert scale (1=completely satisfied, 2= rather satisfied, 3= unchanged, 4= rather dissatisfied, 5= completely dissatisfied).

    3. biochemical responses to Lanreotide ATG 120 mg in combination with Metformin [1 year]

      Biochemical progression will be evaluated testing Chromogranin A, NSE, 5-HIAA (only if functioning tumours) at each 4th month

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NationalCIMilan Milan Italy 20133

    Sponsors and Collaborators

    • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    Investigators

    • Principal Investigator: Sara Pusceddu, MD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cecilia Melani, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    ClinicalTrials.gov Identifier:
    NCT02823691
    Other Study ID Numbers:
    • NationalCIMilan
    First Posted:
    Jul 6, 2016
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jun 1, 2021
    Keywords provided by Cecilia Melani, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    NETs
    Additional relevant MeSH terms:
    Neuroendocrine Tumors
    Metformin
    Lanreotide

    Study Results

    No Results Posted as of Jun 7, 2021