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A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors (MetNet)

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ClinicalTrials.gov Identifier: NCT02279758
Recruitment Status : Unknown
Verified October 2014 by Instituto do Cancer do Estado de São Paulo.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

Tracking Information
First Submitted Date  ICMJE July 7, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date October 31, 2014
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
Disease free survival [ Time Frame: After 180 days of treatment. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
  • Number of Participants with Adverse Events Related to Metformin Measured of Safety and Tolerability [ Time Frame: Assessments will be performed until 180 days after treatment initiation ]
    Clinical evaluation of metformin related toxicity will be assessed at each medical visit (once a month).
  • Clinical benefit [ Time Frame: Assessments will be performed until 180 days after treatment initiation. ]
    Clinical benefit will be measured using CTCAE version 4.03 for analysis of adverse events presented by patients.
  • Biochemical response [ Time Frame: Assessment will be performed at day 90 and 180 of treatment. ]
    Biochemical response defined by tumor markers.
  • Evaluation of patient`s glycemic profile [ Time Frame: Assessment will be performed at day 90 and day 180 of treatment. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors
Official Title  ICMJE A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS
Brief Summary

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.

Eligible 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Well-differentiated Neuroendocrine Tumors
Intervention  ICMJE Drug: Metformin
Study Arms  ICMJE Experimental: METFORMIN
850mg of metformin every 12 hours.
Intervention: Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 30, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic well-differentiated neuroendocrine tumor grade 1 or 2 with histological confirmation;
  • Performance status according to Eastern Cooperative Oncology Group (ECOG) 0 to 2;
  • Able to take pills;
  • Age ≥ 16 years;
  • Ability to Provide Written Informed Consent;
  • Adequate organ function;

Exclusion Criteria:

  • Patient with out of control severe hormonal syndrome;
  • Diabetic patients under metformin treatment, or those who have received treatment with metformin within 3 months;
  • Patient with hypersensitivity to biguanides, kidney or liver failure, or other conditions that predispose to lactic acidosis;
  • History of severe clinical or psychiatric illness, that would prevent participation in the study by clinical judgment;
  • Patients who participate in other protocol with experimental drugs;
  • Patients under any kind of active infection;
  • Patients who have received chemotherapy within 3 weeks;
  • Patients pregnant or lactating;
  • Diabetic patients who require higher dose of metformin 850mg x 2 daily;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02279758
Other Study ID Numbers  ICMJE NP 515/2014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto do Cancer do Estado de São Paulo
Study Sponsor  ICMJE Instituto do Cancer do Estado de São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: João Glasberg, MD Instituto do Cancer do Estado de São Paulo
PRS Account Instituto do Cancer do Estado de São Paulo
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP