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NCT00519090 · ClinicalTrials.gov registry record · Phase 3
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 6
- Enrollment target
NCT00519090: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00519090 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 6 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00519090, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 6 participants
- Enrollment target
Study Summary
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Primary Outcome
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Interventions
- DRUG Imatinib
- DRUG Nilotinib (AMN107)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
Why NCT00519090 stopped before completion
NCT00519090 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Imatinib is the first listed.
NCT00519090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00519090 about?
NCT00519090 is a clinical study titled "Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)". In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
What is the current status of trial NCT00519090?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2007-10. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00519090?
The interventions under investigation include: Imatinib (DRUG), Nilotinib (AMN107) (DRUG).
Who is sponsoring clinical trial NCT00519090?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00519090's enrollment target sits among peer trials
6 1995th of 2000 higher than 4 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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