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NCT00985530 · ClinicalTrials.gov registry record · Phase 1
Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
A Phase 1 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00985530: Clinical Trial Phase 1 study, sponsored by Northwestern University.
NCT00985530 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00985530, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial treatment or has not gone away with initial therapy. This research study involves testing an investigational drug called Tamibarotene in combination with standard treatment for relapsed APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of this study is to determine if tamibarotene in combination with arsenic trioxide is safe and effective.
Interventions
- DRUG Tamibarotene
- DRUG Arsenic trioxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
Why NCT00985530 stopped before completion
NCT00985530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Tamibarotene is the first listed.
NCT00985530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00985530 about?
NCT00985530 is a clinical study titled "Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia". Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial treatment or has not gone away with initial therapy. This research study involves testing an investigational drug called Tamibarotene in combination with standard treatment for relapsed APL called arsenic tr...
What is the current status of trial NCT00985530?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2009-10. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00985530?
The interventions under investigation include: Tamibarotene (DRUG), Arsenic trioxide (DRUG).
Who is sponsoring clinical trial NCT00985530?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00985530's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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