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NCT02390843 · ClinicalTrials.gov registry record · Phase 1
Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02390843: Completed Phase 1 study, sponsored by Emory University.
NCT02390843 is a Phase 1 study that has completed, run by Emory University. 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
NCT02390843, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a Phase I trial with new experimental drugs such as simvastatin in combination with topotecan and cyclophosphamide in the hopes of finding a drug that may work against tumors that have come back or that have not responded to standard therapy. This study will define toxicity of high dose simvastatin in combination with topotecan and cyclophosphamide and evaluate for cholesterol levels and IL6/STAT3 pathway changes as biomarkers of patient response.
Primary Outcome
MTD will be the maximum dose at which fewer than one-third of subjects experience dose-limiting toxicities (DLTs) during Cycle 1 of therapy.
Interventions
- DRUG Cyclophosphamide
- DRUG Topotecan
- DRUG Simvastatin
- DRUG Myeloid growth factor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-02 |
| Est. Completion | 2019-09-22 |
| Phase | Phase 1 |
What the finished NCT02390843 record still lists
NCT02390843 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 4 interventions - of which Cyclophosphamide is the first listed.
NCT02390843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02390843 about?
NCT02390843 is a clinical study titled "Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors". This is a Phase I trial with new experimental drugs such as simvastatin in combination with topotecan and cyclophosphamide in the hopes of finding a drug that may work against tumors that have come back or that have not responded to standard therapy. This study will define toxicity of high dose simv...
What is the current status of trial NCT02390843?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2015-02. Estimated completion is 2019-09-22.
What interventions are being tested in trial NCT02390843?
The interventions under investigation include: Cyclophosphamide (DRUG), Topotecan (DRUG), Simvastatin (DRUG), Myeloid growth factor (DRUG).
Who is sponsoring clinical trial NCT02390843?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02390843'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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