Well-differentiated Neuroendocrine TumorsPhase 2MetNetNCT02279758
A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors
A Phase 2 study testing Metformin in people with Well-differentiated Neuroendocrine Tumors, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Well-differentiated Neuroendocrine Tumors
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- Patients who have received chemotherapy within 3 weeks;
- Patients pregnant or lactating;
- Diabetic patients who require higher dose of metformin 850mg x 2 daily;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Cancer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
João Glasberg, MD, 55 11 38932000, pesquisa.clinica@icesp.org.br
About this study
Official title: A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS
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.
- Being tested
- Metformin
- Keywords
- Neuroendocrine Tumors, The Mammalian Target of Rapamycin (mTOR), metformin
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| METFORMIN | Experimental | 850mg of metformin every 12 hours. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: After 180 days of treatment.
Secondary outcomes (4)
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).
Measured: Assessments will be performed until 180 days after treatment initiation
Clinical benefit
Clinical benefit will be measured using CTCAE version 4.03 for analysis of adverse events presented by patients.
Measured: Assessments will be performed until 180 days after treatment initiation.
Biochemical response
Biochemical response defined by tumor markers.
Measured: Assessment will be performed at day 90 and 180 of treatment.
Evaluation of patient's glycemic profile
Measured: Assessment will be performed at day 90 and day 180 of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-differentiated Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Glasberg, MD, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279758
- Sponsor's protocol ID
- NP 515/2014
- Acronym
- MetNet
- Status last verified
- Oct 2014
- First submitted
- 7 Jul 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS
- ClinicalTrials.gov ID
- NCT02279758
- Acronym / sponsor ID
- MetNet / NP 515/2014
- Keywords
- Neuroendocrine Tumors, The Mammalian Target of Rapamycin (mTOR), metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| METFORMIN | Experimental | Drug: Metformin850mg of metformin every 12 hours. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | METFORMIN |
Primary outcome
Disease free survival
Time frame: After 180 days of treatment.
4 secondary outcomes
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 benefit
Time frame: Assessments will be performed until 180 days after treatment initiation.
Biochemical response
Time frame: Assessment will be performed at day 90 and 180 of treatment.
Evaluation of patient's glycemic profile
Time frame: Assessment will be performed at day 90 and day 180 of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Glasberg, MD principal investigator
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Well-differentiated Neuroendocrine Tumors, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Glasberg, MD (55 11 38932000, pesquisa.clinica@icesp.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: After 180 days of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.