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NCT00574873 · ClinicalTrials.gov registry record · Phase 3
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 502
- Enrollment target
NCT00574873: Completed Phase 3 study, sponsored by Pfizer.
NCT00574873 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 502 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00574873, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 502 participants
- Enrollment target
Study Summary
Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.
Primary Outcome
Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (\<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.
Interventions
- DRUG Bosutinib
- DRUG imatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2008-02-05 |
| Est. Completion | 2015-05-27 |
| Phase | Phase 3 |
What the finished NCT00574873 record still lists
NCT00574873 is an interventional study that assigns participants to a tested intervention. The registered 502 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Bosutinib is the first listed.
NCT00574873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00574873 about?
NCT00574873 is a clinical study titled "Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML". Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.
What is the current status of trial NCT00574873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2008-02-05. Estimated completion is 2015-05-27.
What interventions are being tested in trial NCT00574873?
The interventions under investigation include: Bosutinib (DRUG), imatinib (DRUG).
Who is sponsoring clinical trial NCT00574873?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00574873's enrollment target sits among peer trials
502 743rd of 2000 higher than 1,258 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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