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Completed Phase 1 Interventional

Metformin in Children With Relapsed or Refractory Solid Tumors

ClinicalTrials.gov ID: NCT01528046

Public ClinicalTrials.gov record NCT01528046. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 7:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I Trial of Dose Escalation of Metformin in Combination With Vincristine, Irinotecan, and Temozolomide in Children With Relapsed or Refractory Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the tolerability and safety of escalating doses of metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with recurrent and refractory solid tumors.

Study identification

NCT ID
NCT01528046
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
26 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Year to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 24, 2012 (Actual)
Primary completion
Sep 26, 2019 (Actual)
Completion
Feb 3, 2020 (Actual)
Last update posted
Jan 13, 2023

2012 – 2020

United States locations

U.S. sites
14
U.S. states
9
U.S. cities
13
Facility City State ZIP Site status
Connecticut Children's Medical Center Hartford Connecticut 06106 —
Nemours/Alfred I. duPont Hospital for Children, Delaware Wilmington Delaware 19803 —
University of Florida Gainesville Florida 32611 —
Nemours Children's Clinic Jacksonville Florida 32207 —
University of Miami Sylvester Comprehensive Cancer Center Miami Florida 33136 —
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 —
Tampa General Hospital Tampa Florida 33606 —
H. Lee Moffitt Cancer Center and Research Institute Tampa Florida 33612 —
University of Kentucky Lexington Kentucky 40536 —
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland 21231 —
The Children's Hospital at Montefiore The Bronx New York 10467 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Primary Children's Medical Center/Utah Salt Lake City Utah 84113 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01528046, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 13, 2023 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01528046 live on ClinicalTrials.gov.

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