The MetNET-2 Trial (MetNET-2)
Primary Purpose
Neuroendocrine Tumors
Status
Unknown status
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Lanreotide and Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring NETs
Eligibility 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
Sites / Locations
- NationalCIMilan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lanreotide and Metformin
Arm Description
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.
Outcomes
Primary Outcome Measures
incidence of SAEs and AEs
Secondary Outcome Measures
time to progression (TTP) to Lanreotide ATG 120 mg in combination with Metformin
This is a pilot study. This endpoints should be considered an exploratory evaluation
symptomatic responses to Lanreotide ATG 120 mg in combination with Metformin in symptomatic patients
Answers will be based on a 5 point Likert scale (1=completely satisfied, 2= rather satisfied, 3= unchanged, 4= rather dissatisfied, 5= completely dissatisfied).
biochemical responses to Lanreotide ATG 120 mg in combination with Metformin
Biochemical progression will be evaluated testing Chromogranin A, NSE, 5-HIAA (only if functioning tumours) at each 4th month
Full Information
NCT ID
NCT02823691
First Posted
May 19, 2016
Last Updated
June 4, 2021
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1. Study Identification
Unique Protocol Identification Number
NCT02823691
Brief Title
The MetNET-2 Trial
Acronym
MetNET-2
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 Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
NETs
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lanreotide and Metformin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lanreotide and Metformin
Other Intervention Name(s)
Ipstyl and Metformin
Intervention Description
Lanreotide and Metformin
Primary Outcome Measure Information:
Title
incidence of SAEs and AEs
Time Frame
1 year
Secondary Outcome Measure Information:
Title
time to progression (TTP) to Lanreotide ATG 120 mg in combination with Metformin
Description
This is a pilot study. This endpoints should be considered an exploratory evaluation
Time Frame
3 years
Title
symptomatic responses to Lanreotide ATG 120 mg in combination with Metformin in symptomatic patients
Description
Answers will be based on a 5 point Likert scale (1=completely satisfied, 2= rather satisfied, 3= unchanged, 4= rather dissatisfied, 5= completely dissatisfied).
Time Frame
1 year
Title
biochemical responses to Lanreotide ATG 120 mg in combination with Metformin
Description
Biochemical progression will be evaluated testing Chromogranin A, NSE, 5-HIAA (only if functioning tumours) at each 4th month
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Pusceddu, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
NationalCIMilan
City
Milan
ZIP/Postal Code
20133
Country
Italy
12. IPD Sharing Statement
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The MetNET-2 Trial
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