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NCT02228382 · ClinicalTrials.gov registry record · Phase 4
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
A Phase 4 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 4
- Development phase
- 163
- Enrollment target
NCT02228382: Clinical Trial Phase 4 study, sponsored by Pfizer.
NCT02228382 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 163 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02228382, a Phase 4 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 163 participants
- Enrollment target
Study Summary
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).
Primary Outcome
Confirmed MCyR: confirmed (complete cytogenetic response\[CCyR\] or partial cytogenetic response\[PCyR\]) by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least major molecular response(MMR) by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Init
Interventions
- DRUG Bosutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2014-11-07 |
| Est. Completion | 2020-10-13 |
| Phase | Phase 4 |
Why NCT02228382 stopped before completion
NCT02228382 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which Bosutinib is the first listed.
NCT02228382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02228382 about?
NCT02228382 is a clinical study titled "Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors". The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 7...
What is the current status of trial NCT02228382?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 163 participants. The study started on 2014-11-07. Estimated completion is 2020-10-13.
What interventions are being tested in trial NCT02228382?
The interventions under investigation include: Bosutinib (DRUG).
Who is sponsoring clinical trial NCT02228382?
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 NCT02228382's enrollment target sits among peer trials
163 501st of 2000 higher than 1,498 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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