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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 is a Phase 1 study that has completed, run by Giselle Sholler. The registered enrollment target is 18 participants.
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.
Interventions
- DRUG TPI 287
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-03 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00867568
The ClinicalTrials.gov registry entry for NCT00867568 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Giselle Sholler, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TPI 287 is the first listed.
NCT00867568 reports 0 study locations.
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.
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