Current partner codePEPTIDESDE
NCT02823691·Early Phase 1·INTERVENTIONAL

The MetNET-2 Trial

Status

Unknown

Phase

Early Phase 1

Enrollment

20

Locations

1

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Lanreotide and Metformin

Lanreotide and Metformin

Timeline

From registration to results.

  1. First posted

    Jul 6, 2016

  2. Study start

    Apr 2016

  3. Primary completion

    Dec 2021

  4. Study completion

    Dec 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jun 7, 2021

Outcomes

What the study measures.

Primary outcomes

incidence of SAEs and AEs

Time frame · 1 year

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

NationalCIMilan

Milan, Italy

Publications

Results and literature.

PMID 21369878Culler MD, Oberg K, Arnold R, Krenning EP, Sevilla I, Diaz JA. Somatostatin analogs for the treatment of neuroendocrine tumors. Cancer Metastasis Rev. 2011 Mar;30 Suppl 1:9-17. doi: 10.1007/s10555-011-9293-0.PMID 23499688Rizos CV, Elisaf MS. Metformin and cancer. Eur J Pharmacol. 2013 Apr 5;705(1-3):96-108. doi: 10.1016/j.ejphar.2013.02.038. Epub 2013 Mar 13.PMID 25014687Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.PMID 15849206Evans JM, Donnelly LA, Emslie-Smith AM, Alessi DR, Morris AD. Metformin and reduced risk of cancer in diabetic patients. BMJ. 2005 Jun 4;330(7503):1304-5. doi: 10.1136/bmj.38415.708634.F7. Epub 2005 Apr 22. No abstract available.PMID 20947488Decensi A, Puntoni M, Goodwin P, Cazzaniga M, Gennari A, Bonanni B, Gandini S. Metformin and cancer risk in diabetic patients: a systematic review and meta-analysis. Cancer Prev Res (Phila). 2010 Nov;3(11):1451-61. doi: 10.1158/1940-6207.CAPR-10-0157. Epub 2010 Oct 12.PMID 19487376Jiralerspong S, Palla SL, Giordano SH, Meric-Bernstam F, Liedtke C, Barnett CM, Hsu L, Hung MC, Hortobagyi GN, Gonzalez-Angulo AM. Metformin and pathologic complete responses to neoadjuvant chemotherapy in diabetic patients with breast cancer. J Clin Oncol. 2009 Jul 10;27(20):3297-302. doi: 10.1200/JCO.2009.19.6410. Epub 2009 Jun 1.PMID 17307971Towler MC, Hardie DG. AMP-activated protein kinase in metabolic control and insulin signaling. Circ Res. 2007 Feb 16;100(3):328-41. doi: 10.1161/01.RES.0000256090.42690.05.PMID 19574203Vazquez-Martin A, Oliveras-Ferraros C, del Barco S, Martin-Castillo B, Menendez JA. mTOR inhibitors and the anti-diabetic biguanide metformin: new insights into the molecular management of breast cancer resistance to the HER2 tyrosine kinase inhibitor lapatinib (Tykerb). Clin Transl Oncol. 2009 Jul;11(7):455-9. doi: 10.1007/s12094-009-0384-0.PMID 19844168Vazquez-Martin A, Oliveras-Ferraros C, Lopez-Bonet E, Menendez JA. AMPK: Evidence for an energy-sensing cytokinetic tumor suppressor. Cell Cycle. 2009 Nov 15;8(22):3679-83. doi: 10.4161/cc.8.22.9905. Epub 2009 Nov 24.PMID 10679645O'Toole D, Ducreux M, Bommelaer G, Wemeau JL, Bouche O, Catus F, Blumberg J, Ruszniewski P. Treatment of carcinoid syndrome: a prospective crossover evaluation of lanreotide versus octreotide in terms of efficacy, patient acceptability, and tolerance. Cancer. 2000 Feb 15;88(4):770-6. doi: 10.1002/(sici)1097-0142(20000215)88:43.0.co;2-0.PMID 24053191Martin-Richard M, Massuti B, Pineda E, Alonso V, Marmol M, Castellano D, Fonseca E, Galan A, Llanos M, Sala MA, Pericay C, Rivera F, Sastre J, Segura A, Quindos M, Maisonobe P; TTD (Tumores del Tracto Digestivo) Study Group. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study. BMC Cancer. 2013 Sep 20;13:427. doi: 10.1186/1471-2407-13-427.PMID 19629071Shackelford DB, Shaw RJ. The LKB1-AMPK pathway: metabolism and growth control in tumour suppression. Nat Rev Cancer. 2009 Aug;9(8):563-75. doi: 10.1038/nrc2676.

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