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

NCT02279758 | Unknown Phase 2

• 1 other identifier: NP 515/2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-differentiated Neuroendocrine Tumors

Keywords

Neuroendocrine Tumors; The Mammalian Target of Rapamycin (mTOR); metformin

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  After 180 days of treatment.

Secondary Outcomes (4)

• Number of Participants with Adverse Events Related to Metformin Measured of Safety and Tolerability

  Assessments will be performed until 180 days after treatment initiation

• Clinical benefit

  Assessments will be performed until 180 days after treatment initiation.

• Biochemical response

  Assessment will be performed at day 90 and 180 of treatment.

• Evaluation of patient's glycemic profile

  Assessment will be performed at day 90 and day 180 of treatment.

Study Arms (1)

METFORMIN

EXPERIMENTAL

850mg of metformin every 12 hours.

Drug: Metformin

Interventions

Metformin DRUG

METFORMIN

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Cancer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• João Glasberg, MD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Glasberg, MD

CONTACT

55 11 38932000; pesquisa.clinica@icesp.org.br

Rachel Riechelmann, MD

CONTACT

55 11 38932000; pesquisa.clinica@icesp.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: October 31, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2017
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

BR (1)