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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: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Establish the recommended phase II dose of the combination of topotecan and sorafenib in children. This will be the maximum tolerated dose.
Interventions
- DRUG Topotecan
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT01683149 record still lists
NCT01683149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Topotecan is the first listed.
NCT01683149 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01683149's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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