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NCT01528046 · ClinicalTrials.gov registry record · Phase 1

Metformin in Children With Relapsed or Refractory Solid Tumors

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT01528046 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 26 participants.

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The verdict

NCT01528046, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Temozolomide
  • DRUG Metformin
  • DRUG Vincristine
  • DRUG Irinotecan

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2012-09-24
Est. Completion 2020-02-03
Phase Phase 1

What the Registry Record Tells You About NCT01528046

The ClinicalTrials.gov registry entry for NCT01528046 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.

NCT01528046 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01528046 about?

NCT01528046 is a clinical study titled "Metformin in Children With Relapsed or Refractory Solid Tumors". 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.

What is the current status of trial NCT01528046?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2012-09-24. Estimated completion is 2020-02-03.

What interventions are being tested in trial NCT01528046?

The interventions under investigation include: Temozolomide (DRUG), Metformin (DRUG), Vincristine (DRUG), Irinotecan (DRUG).

Who is sponsoring clinical trial NCT01528046?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.