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NCT00261846 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 571
- Enrollment target
NCT00261846: Completed Phase 2 study, sponsored by Pfizer.
NCT00261846 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 571 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (329% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00261846, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 571 participants
- Enrollment target
Study Summary
This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.
Primary Outcome
DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).
Interventions
- DRUG Bosutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 571 participants |
| Start Date | 2006-01-18 |
| Est. Completion | 2015-08-06 |
| Phase | Phase 2 |
What the finished NCT00261846 record still lists
NCT00261846 is an interventional study that assigns participants to a tested intervention. The registered 571 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (329% higher).
The record links to 0 conditions, and to 1 intervention - of which Bosutinib is the first listed.
NCT00261846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00261846 about?
NCT00261846 is a clinical study titled "Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias". This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) ...
What is the current status of trial NCT00261846?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 571 participants. The study started on 2006-01-18. Estimated completion is 2015-08-06.
What interventions are being tested in trial NCT00261846?
The interventions under investigation include: Bosutinib (DRUG).
Who is sponsoring clinical trial NCT00261846?
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 NCT00261846's enrollment target sits among peer trials
571 59th of 2000 higher than 1,941 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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