A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors (MetNet)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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.
|Condition or disease||Intervention/treatment||Phase|
|Well-differentiated Neuroendocrine Tumors||Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2017|
850mg of metformin every 12 hours.
- Disease free survival [ Time Frame: After 180 days of treatment. ]
- 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. ]
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): NCT02279758
|Contact: João Glasberg, MD||55 11 email@example.com|
|Contact: Rachel Riechelmann, MD||55 11 firstname.lastname@example.org|
|Instituto do Cancer do Estado de São Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 01246-000|
|Contact: João Glasberg, MD 55 11 38932000 email@example.com|
|Principal Investigator:||João Glasberg, MD||Instituto do Cancer do Estado de São Paulo|