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NCT00867568 · ClinicalTrials.gov registry record · Phase 1
TPI 287 in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma
A Phase 1 study, sponsored by Giselle Sholler.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00867568: Completed Phase 1 study, sponsored by Giselle Sholler.
NCT00867568 is a Phase 1 study that has completed, run by Giselle Sholler. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00867568, a Phase 1 study, has completed, sponsored by Giselle Sholler.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a currently approved drug). 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 safety and tolerability of TPI 287 both alone and in combination with temozolomide, and look to establish a safe dose of this agent. The study will also look at the tumor's response to these drugs, but this is not the primary objective of this study. 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. All of these subjects that have received TPI 287 have been adults. TPI 287 has not been tested in a pediatric population before this study. Temozolomide was tested in recurrent neuroblastoma and showed activity in a recently published study. Preclinical studies of TPI in combination with temozolomide have shown at minimum an additive effect. The ability of temozolomide and TPI 287 to be effective in combination is suggested by these two drugs showing even greater activity when used together.
Primary Outcome
To determine the safety, tolerability and maximum tolerated dose (MTD) of TPI 287 as a single agent and collect exploratory data on the safety and tolerability of TPI 287 in combination with temozolomide (TMZ) in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma
Interventions
- DRUG TPI 287
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-03 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT00867568 record still lists
NCT00867568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which TPI 287 is the first listed.
NCT00867568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00867568 about?
NCT00867568 is a clinical study titled "TPI 287 in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma". The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a currently approved drug). An investigational drug is one that has not yet been approved by the Food and Drug Administration....
What is the current status of trial NCT00867568?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2009-03. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00867568?
The interventions under investigation include: TPI 287 (DRUG).
Who is sponsoring clinical trial NCT00867568?
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 NCT00867568's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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