The MetNET-2 Trial (MetNET-2)
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|ClinicalTrials.gov Identifier: NCT02823691|
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
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|
|Neuroendocrine Tumors||Drug: Lanreotide and Metformin||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||April 2016|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
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 Name: Ipstyl and Metformin
- incidence of SAEs and AEs [ Time Frame: 1 year ]
- time to progression (TTP) to Lanreotide ATG 120 mg in combination with Metformin [ Time Frame: 3 years ]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 [ Time Frame: 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).
- biochemical responses to Lanreotide ATG 120 mg in combination with Metformin [ Time Frame: 1 year ]Biochemical progression will be evaluated testing Chromogranin A, NSE, 5-HIAA (only if functioning tumours) at each 4th month
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823691
|Contact: Sara Pusceddu, MDemail@example.com|
|Milan, Italy, 20133|
|Contact: Sara Pusceddu, MD +390223903251 firstname.lastname@example.org|
|Principal Investigator:||Sara Pusceddu, MD|