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NCT01683149 · ClinicalTrials.gov registry record · Phase 1

Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies

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

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT01683149 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 13 participants.

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The verdict

NCT01683149, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting locally. The purpose of this research study is to establish a dose of the combination of drugs, Topotecan and Sorafenib in children. This will be called the maximum tolerated dose. The chemotherapy in this study is a combination of Topotecan and Sorafenib. The investigators are trying to find the highest dose of Topotecan and Sorafenib that can be given safely to children with Refractory or Recurrent Pediatric Solid Malignancies. The investigators will do this by testing different doses of these drugs in different groups of children. The investigators will also study how the body processes these drugs.

Interventions

  • DRUG Topotecan
  • DRUG Sorafenib

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2013-01
Est. Completion 2016-01
Phase Phase 1

What the Registry Record Tells You About NCT01683149

The ClinicalTrials.gov registry entry for NCT01683149 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 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 2 interventions - of which Topotecan is the first listed.

NCT01683149 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01683149 about?

NCT01683149 is a clinical study titled "Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies". H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting locally. The purpose of this research study is to establish a dose of the combination of drugs, Topotecan and Sorafenib in children. This will be called the maximum tolerated dos...

What is the current status of trial NCT01683149?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2013-01. Estimated completion is 2016-01.

What interventions are being tested in trial NCT01683149?

The interventions under investigation include: Topotecan (DRUG), Sorafenib (DRUG).

Who is sponsoring clinical trial NCT01683149?

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.