Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
EARLY_PHASE1
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-30
Study Completion Date
2021-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Neuroendocrine Tumors
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Lanreotide and Metformin
Intervention Type
DRUG
Lanreotide and Metformin
Interventions
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Lanreotide and Metformin
Lanreotide and Metformin
Intervention Type
DRUG
Other Intervention Names
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Ipstyl and Metformin
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Sponsor Role
lead
Responsible Party
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Cecilia Melani
MD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Sara Pusceddu, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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NationalCIMilan
Milan, , Italy
Site Status
Countries
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Italy
References
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Culler 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.
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Caplin 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.
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Vlotides G et Al: anticancer effects of metformin on neuroendocrine tumor cell in vitro. 10 the ENETs Annual conference Barcelona 5-8 March 2013
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Evans 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.
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O'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.
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Vlotides G et al. "In Vitro Anticancer Effect of Metformin in Neuroendocrine Tumour Cells" Abstract B9; 10th Annual ENETS Conference, 6-8 March 2013, Barcelona
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S. Pusceddu, et al. "Metformin impact on progression-free survival in advanced pancreatic well-differentiated neuroendocrine tumors (pWDNETs). Retrospective evaluation in diabetic patients receiving Everolimus plus Octreotide LAR treatment" 1146Tip - 39th ESMO Congress, Madrid - Annals of Oncology, Vol 25, Suppl 4, 2014
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F.G.M. De Braud, et al. "Activity and safety of Everolimus in combination with Octreotide LAR and Metformin in patients with advanced pancreatic well-differentiated Neuroendocrine Tumors (pWDNETs): a single-center, open-label, phase II, proof-of-concept study (MetNET1 trial)"; 1163Tip - 39th ESMO Congress, Madrid - Annals of Oncology, Vol 25, Suppl 4, 2014
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Custodio A et al. "Prognostic Role of Diabetes Mellitus (DM) and Metformin (MET) Therapy in Patients (pts) with Advanced G1-G2 Neuroendocrine Tumors (NETs) Treated with Everolimus (EVE)" - abstract L7, ENETS 2015
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BACKGROUND
Rodbard HW, Blonde L, Braithwaite SS, Brett EM, Cobin RH, Handelsman Y, Hellman R, Jellinger PS, Jovanovic LG, Levy P, Mechanick JI, Zangeneh F; AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007 May-Jun;13 Suppl 1:1-68. doi: 10.4158/EP.13.S1.1. No abstract available.
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BACKGROUND
Einhorn D, Reaven GM, Cobin RH, Ford E, Ganda OP, Handelsman Y, Hellman R, Jellinger PS, Kendall D, Krauss RM, Neufeld ND, Petak SM, Rodbard HW, Seibel JA, Smith DA, Wilson PW. American College of Endocrinology position statement on the insulin resistance syndrome. Endocr Pract. 2003 May-Jun;9(3):237-52. No abstract available.
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BACKGROUND
Modlin IM, Pavel M, Kidd M, Gustafsson BI. Review article: somatostatin analogues in the treatment of gastroenteropancreatic neuroendocrine (carcinoid) tumours. Aliment Pharmacol Ther. 2010 Jan 15;31(2):169-88. doi: 10.1111/j.1365-2036.2009.04174.x. Epub 2009 Oct 21.
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BACKGROUND
Jiao Y, Shi C, Edil BH, de Wilde RF, Klimstra DS, Maitra A, Schulick RD, Tang LH, Wolfgang CL, Choti MA, Velculescu VE, Diaz LA Jr, Vogelstein B, Kinzler KW, Hruban RH, Papadopoulos N. DAXX/ATRX, MEN1, and mTOR pathway genes are frequently altered in pancreatic neuroendocrine tumors. Science. 2011 Mar 4;331(6021):1199-203. doi: 10.1126/science.1200609. Epub 2011 Jan 20.
Reference Type
RESULT
Wolin EM. The expanding role of somatostatin analogs in the management of neuroendocrine tumors. Gastrointest Cancer Res. 2012 Sep;5(5):161-8.
Reference Type
RESULT
Other Identifiers
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NationalCIMilan
Identifier Type: -
Identifier Source: org_study_id
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