Status:
UNKNOWN
A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Well-differentiated Neuroendocrine Tumors
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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 ther...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02279758
Start Date
March 1 2014
Last Update
October 31 2014
Active Locations (1)
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1
Instituto do Cancer do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000