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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 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 571 participants.
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.
Interventions
- DRUG Bosutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 571 participants |
| Start Date | 2006-01-18 |
| Est. Completion | 2015-08-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00261846
The ClinicalTrials.gov registry entry for NCT00261846 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 571 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bosutinib is the first listed.
NCT00261846 reports 0 study locations.
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.
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