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NCT01131325 · ClinicalTrials.gov registry record · Phase 4
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT01131325: Clinical Trial Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01131325 is a Phase 4 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01131325, a Phase 4 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.
Primary Outcome
Treatment failure events from time of study entry in Complete molecular response-Chronic phase (CML-CP) participants with low imatinib trough concentrations less than 850 nanogram per milliliter (\<850 ng/mL) treated with nilotinib as defined in European LeukemiaNet (ELN)-guideline.
Interventions
- DRUG nilotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-10-21 |
| Est. Completion | 2011-05-12 |
| Phase | Phase 4 |
Why NCT01131325 stopped before completion
NCT01131325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which nilotinib is the first listed.
NCT01131325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01131325 about?
NCT01131325 is a clinical study titled "Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations". This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.
What is the current status of trial NCT01131325?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2010-10-21. Estimated completion is 2011-05-12.
What interventions are being tested in trial NCT01131325?
The interventions under investigation include: nilotinib (DRUG).
Who is sponsoring clinical trial NCT01131325?
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 NCT01131325's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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