Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT02279758
Status:
UNKNOWN
Last Update Posted:
2014-10-31
First Post:
2014-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': 'After 180 days of treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events Related to Metformin Measured of Safety and Tolerability', 'timeFrame': 'Assessments will be performed until 180 days after treatment initiation', 'description': 'Clinical evaluation of metformin related toxicity will be assessed at each medical visit (once a month).'}, {'measure': 'Clinical benefit', 'timeFrame': 'Assessments will be performed until 180 days after treatment initiation.', 'description': 'Clinical benefit will be measured using CTCAE version 4.03 for analysis of adverse events presented by patients.'}, {'measure': 'Biochemical response', 'timeFrame': 'Assessment will be performed at day 90 and 180 of treatment.', 'description': 'Biochemical response defined by tumor markers.'}, {'measure': "Evaluation of patient's glycemic profile", 'timeFrame': 'Assessment will be performed at day 90 and day 180 of treatment.'}]}, 'conditionsModule': {'keywords': ['Neuroendocrine Tumors', 'The Mammalian Target of Rapamycin (mTOR)', 'metformin'], 'conditions': ['Well-differentiated Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence. The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may be an alternative treatment for this disease.\n\nEligible patients for this study should have metastatic gastroenteropancreatic neuroendocrine tumors well differentiated (grade 1 or grade 2) and will be treated with metformin 850 mg every 12 hours, and each cycle will consist of 30 days. After 180 days of treatment the efficacy of metformin under the control of disease progression will be evaluated. As a secondary outcome the investigator will check the patient adherence to the treatment, the control of patient symptoms with functioning neuroendocrine tumor, and disease free survival. Also will be performed an analysis of immunohistochemical expression of mTOR pathway proteins of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic well-differentiated neuroendocrine tumor grade 1 or 2 with histological confirmation;\n* Performance status according to Eastern Cooperative Oncology Group (ECOG) 0 to 2;\n* Able to take pills;\n* Age ≥ 16 years;\n* Ability to Provide Written Informed Consent;\n* Adequate organ function;\n\nExclusion Criteria:\n\n* Patient with out of control severe hormonal syndrome;\n* Diabetic patients under metformin treatment, or those who have received treatment with metformin within 3 months;\n* Patient with hypersensitivity to biguanides, kidney or liver failure, or other conditions that predispose to lactic acidosis;\n* History of severe clinical or psychiatric illness, that would prevent participation in the study by clinical judgment;\n* Patients who participate in other protocol with experimental drugs;\n* Patients under any kind of active infection;\n* Patients who have received chemotherapy within 3 weeks;\n* Patients pregnant or lactating;\n* Diabetic patients who require higher dose of metformin 850mg x 2 daily;'}, 'identificationModule': {'nctId': 'NCT02279758', 'acronym': 'MetNet', 'briefTitle': 'A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS', 'orgStudyIdInfo': {'id': 'NP 515/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'METFORMIN', 'description': '850mg of metformin every 12 hours.', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'armGroupLabels': ['METFORMIN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'João Glasberg, MD', 'role': 'CONTACT', 'email': 'pesquisa.clinica@icesp.org.br', 'phone': '55 11 38932000'}], 'facility': 'Instituto do Cancer do Estado de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'João Glasberg, MD', 'role': 'CONTACT', 'email': 'pesquisa.clinica@icesp.org.br', 'phone': '55 11 38932000'}, {'name': 'Rachel Riechelmann, MD', 'role': 'CONTACT', 'email': 'pesquisa.clinica@icesp.org.br', 'phone': '55 11 38932000'}], 'overallOfficials': [{'name': 'João Glasberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Cancer do Estado de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}