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NCT01483820 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of TPI-287 in Neuroblastoma and Medulloblastoma
A Phase 1 study, sponsored by Giselle Sholler.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01483820: Clinical Trial Phase 1 study, sponsored by Giselle Sholler.
NCT01483820 is a Phase 1 study that was terminated before completion, run by Giselle Sholler. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01483820, a Phase 1 study, was terminated before completion, sponsored by Giselle Sholler.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tumor's response to the study drug, TPI 287, as well as the safety and tolerability of the drug. TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in three different animal species. TPI 287 has been tested in humans in four clinical trials, and approximately 100 subjects with various types of cancers have received the drug, including a pediatric population in our previous Phase I trial.
Primary Outcome
Phase I portion of trial- To determine the safety and tolerability of TPI 287 as a single agent in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma. Adverse events collected from time of first dose to 30 days past last dose and until all related events resolved, average of one year.
Interventions
- DRUG TPI 287
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
Why NCT01483820 stopped before completion
NCT01483820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which TPI 287 is the first listed.
NCT01483820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01483820 about?
NCT01483820 is a clinical study titled "Safety and Efficacy Study of TPI-287 in Neuroblastoma and Medulloblastoma". The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tu...
What is the current status of trial NCT01483820?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-12. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01483820?
The interventions under investigation include: TPI 287 (DRUG).
Who is sponsoring clinical trial NCT01483820?
This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01483820's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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