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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 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 25 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01041443
The ClinicalTrials.gov registry entry for NCT01041443 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01041443 reports 0 study locations.
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.
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