ClinicalTrials.gov record
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 May 15, 2026, 2:03 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

Study identification

NCT ID
NCT01528046
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Enrollment
26 participants

Conditions and interventions

Interventions

  • Irinotecan Drug
  • Metformin Drug
  • Temozolomide Drug
  • Vincristine Drug

Drug

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 23, 2012
Primary completion
Sep 25, 2019
Completion
Feb 2, 2020
Last update posted
Jan 12, 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 12, 2023 · Synced May 15, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01528046 live on ClinicalTrials.gov.

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