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NCT00493571 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00493571: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00493571 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00493571, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of gimatecan that can be given to treat myelodysplastic syndrome (MDS).
Primary Outcome
For purposes of estimating the MTD, 5 dose levels of Gimatecan initially considered. These dose levels are 3 mg, 5 mg, 7.5 mg, 8.75 mg, and 10 mg orally per cycle. Dose escalation based on toxicities observed through the first cycle.
Interventions
- DRUG Gimatecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-08 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT00493571 record still lists
NCT00493571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Gimatecan is the first listed.
NCT00493571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00493571 about?
NCT00493571 is a clinical study titled "Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes". The goal of this clinical research study is to find the highest tolerable dose of gimatecan that can be given to treat myelodysplastic syndrome (MDS).
What is the current status of trial NCT00493571?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2007-08. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00493571?
The interventions under investigation include: Gimatecan (DRUG).
Who is sponsoring clinical trial NCT00493571?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00493571's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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