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NCT01041443 · ClinicalTrials.gov registry record · Phase 1
5-Fluoro-2'-Deoxycytidine and Tetrahydrouridine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01041443: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT01041443 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01041443, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of 5-Fluoro-2'-deoxycytidine (FdCyd) when given together with tetrahydrouridine (THU) in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). FdCyd may inhibit cancer cell growth by increasing the production in cells of compounds that suppress growth or by otherwise killing cells. Although FdCyd is stable as a drug solution, it is rapidly inactivated by an enzyme present in people. THU is included in the treatment to inhibit the enzyme, prolonging the time FdCyd remains in the body
Primary Outcome
Toxicities will be summarized by Common Terminology Criteria for Adverse Events (CTCAE) grade and attribution using the version current at the initiation of the protocol.
Interventions
- OTHER laboratory biomarker analysis
- GENETIC DNA methylation analysis
- GENETIC reverse transcriptase-polymerase chain reaction
- DRUG tetrahydrouridine
- DRUG 5-fluoro-2-deoxycytidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01041443 record still lists
NCT01041443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01041443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01041443 about?
NCT01041443 is a clinical study titled "5-Fluoro-2'-Deoxycytidine and Tetrahydrouridine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes". This phase I trial is studying the side effects and best dose of 5-Fluoro-2'-deoxycytidine (FdCyd) when given together with tetrahydrouridine (THU) in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). FdCyd may inhibit cancer cell growth by increasing the produc...
What is the current status of trial NCT01041443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2009-12. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01041443?
The interventions under investigation include: laboratory biomarker analysis (OTHER), DNA methylation analysis (GENETIC), reverse transcriptase-polymerase chain reaction (GENETIC), tetrahydrouridine (DRUG), 5-fluoro-2-deoxycytidine (DRUG).
Who is sponsoring clinical trial NCT01041443?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01041443's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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