Back to results

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

Primary Purpose

Well-differentiated Neuroendocrine Tumors

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Metformin

About this trial

This is an interventional treatment trial for Well-differentiated Neuroendocrine Tumors focused on measuring Neuroendocrine Tumors, The Mammalian Target of Rapamycin (mTOR), metformin

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Instituto do Cancer do Estado de São PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

METFORMIN

Arm Description

850mg of metformin every 12 hours.

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

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).

Clinical benefit

Clinical benefit will be measured using CTCAE version 4.03 for analysis of adverse events presented by patients.

Biochemical response

Biochemical response defined by tumor markers.

Evaluation of patient's glycemic profile

Full Information

NCT ID

NCT02279758

First Posted

July 7, 2014

Last Updated

October 30, 2014

Sponsor

Instituto do Cancer do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02279758

Brief Title

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

Acronym

MetNet

Official Title

A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto do Cancer do Estado de São Paulo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Well-differentiated Neuroendocrine Tumors

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

METFORMIN

Arm Type

Experimental

Arm Description

850mg of metformin every 12 hours.

Intervention Type

Drug

Intervention Name(s)

Metformin

Primary Outcome Measure Information:

Title

Disease free survival

Time Frame

After 180 days of treatment.

Secondary Outcome Measure Information:

Title

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

Description

Clinical evaluation of metformin related toxicity will be assessed at each medical visit (once a month).

Time Frame

Assessments will be performed until 180 days after treatment initiation

Title

Clinical benefit

Description

Clinical benefit will be measured using CTCAE version 4.03 for analysis of adverse events presented by patients.

Time Frame

Assessments will be performed until 180 days after treatment initiation.

Title

Biochemical response

Description

Biochemical response defined by tumor markers.

Time Frame

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

Title

Evaluation of patient's glycemic profile

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

João Glasberg, MD

Phone

55 11 38932000

pesquisa.clinica@icesp.org.br

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Riechelmann, MD

Phone

55 11 38932000

pesquisa.clinica@icesp.org.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

João Glasberg, MD

Organizational Affiliation

Instituto do Cancer do Estado de São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto do Cancer do Estado de São Paulo

City

Sao Paulo

State/Province

ZIP/Postal Code

01246-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

João Glasberg, MD

Phone

55 11 38932000

pesquisa.clinica@icesp.org.br

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs