Well-differentiated Neuroendocrine Tumors Clinical Trial
— MetNetOfficial title:
A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS
| NCT number | NCT02279758 |
| Other study ID # | NP 515/2014 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 2 |
| First received | July 7, 2014 |
| Last updated | October 30, 2014 |
| Start date | March 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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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; |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Instituto do Cancer do Estado de São Paulo | Sao Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto do Cancer do Estado de São Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease free survival | After 180 days of treatment. | Yes | |
| Secondary | Number of Participants with Adverse Events Related to Metformin Measured of Safety and Tolerability | Clinical evaluation of metformin related toxicity will be assessed at each medical visit (once a month). | Assessments will be performed until 180 days after treatment initiation | Yes |
| Secondary | Clinical benefit | Clinical benefit will be measured using CTCAE version 4.03 for analysis of adverse events presented by patients. | Assessments will be performed until 180 days after treatment initiation. | Yes |
| Secondary | Biochemical response | Biochemical response defined by tumor markers. | Assessment will be performed at day 90 and 180 of treatment. | No |
| Secondary | Evaluation of patient`s glycemic profile | Assessment will be performed at day 90 and day 180 of treatment. | Yes |