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NCT01505608 · ClinicalTrials.gov registry record · Phase 1
Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma
A Phase 1 study, sponsored by Giselle Sholler.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01505608: Clinical Trial Phase 1 study, sponsored by Giselle Sholler.
NCT01505608 is a Phase 1 study that was terminated before completion, run by Giselle Sholler. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01505608, a Phase 1 study, was terminated before completion, sponsored by Giselle Sholler.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for early relapsed neuroblastoma. 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, in combination with Irinotecan and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study will also evaluate the safety and tolerability of the study drug, TPI 287.
Primary Outcome
To determine the safety and tolerability of TPI 287 in combination with Irinotecan and Temozolomide (TPI+I+TMZ) in pediatric and young adult patients with primary refractory or recurrent Neuroblastoma. Phase I patients were all enrolled to receive TPI 287. Phase 2 is where randomization began. Patients were different patients than the Phase 1 patients. Below all patients that received TPI 287 are included in the TPI 287 group. This includes Phase I patients and the Phase 2 patients randomized t
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG TPI 287
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
Why NCT01505608 stopped before completion
NCT01505608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT01505608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01505608 about?
NCT01505608 is a clinical study titled "Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma". The purpose of this research study is to evaluate a new investigational drug (TPI 287) for early relapsed neuroblastoma. 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...
What is the current status of trial NCT01505608?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2011-12. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01505608?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), TPI 287 (DRUG).
Who is sponsoring clinical trial NCT01505608?
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 NCT01505608's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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