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NCT00542971 · ClinicalTrials.gov registry record · Phase 1
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT00542971: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00542971 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00542971, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
A primary goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with idarubicin and Ara-C for the treatment of acute myelogenous leukemia (AML) and high-risk, myelodysplastic syndrome (MDS). Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.
Primary Outcome
MTD is dose level where grade 3-4 sorafenib-attributable toxicity in \<2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0.
Interventions
- DRUG Idarubicin
- DRUG Sorafenib
- DRUG Ara-C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
What the finished NCT00542971 record still lists
NCT00542971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 3 interventions - of which Idarubicin is the first listed.
NCT00542971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00542971 about?
NCT00542971 is a clinical study titled "Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)". A primary goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with idarubicin and Ara-C for the treatment of acute myelogenous leukemia (AML) and high-risk, myelodysplastic syndrome (MDS). Once the highest safe dose is found, researche...
What is the current status of trial NCT00542971?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2007-10. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00542971?
The interventions under investigation include: Idarubicin (DRUG), Sorafenib (DRUG), Ara-C (DRUG).
Who is sponsoring clinical trial NCT00542971?
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 NCT00542971's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 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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