Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
Public ClinicalTrials.gov record NCT00261846. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00261846
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 571 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 18, 2006 (Actual)
- Primary completion
- Sep 25, 2009 (Actual)
- Completion
- Aug 6, 2015 (Actual)
- Last update posted
- Jul 27, 2017
2006 – 2015
United States locations
- U.S. sites
- 29
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| HealthONE Presbyterian | Denver | Colorado | 80218 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Emory Clinic | Atlanta | Georgia | 30322 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Oncology Specialists, S.C. | Niles | Illinois | 60714 | — |
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 46237 | — |
| LSU Health Sciences Center | Shreveport | Louisiana | 71103 | — |
| University Of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| University Of Maryland | Baltimore | Maryland | 21201 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Hudson Valley Hematology and Oncology Associates | Hawthorne | New York | 10532 | — |
| Westchester Oncology Hematology Group, P.C. | Hawthorne | New York | 10532 | — |
| Westchester Oncology Hematology, Group, P.C. | Hawthorne | New York | 10532 | — |
| New York Presbyterian Hospital | New York | New York | 10021 | — |
| New York Presbyterian Hospital | New York | New York | 10065 | — |
| University of Rochester Cancer Center Pharmacy | Rochester | New York | 14642 | — |
| University of Rochester Medical Center Strong Memorial Hospital - James P. Wilmot Cancer Center | Rochester | New York | 14642 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| University of Rochester-James P. Wilmot Cancer Center | Rochester | New York | 14642 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Westchester Medical Center | Valhalla | New York | 10595 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030-4009 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| The University of Texas | Houston | Texas | 77030 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298-0157 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 82 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00261846, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2017 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00261846 live on ClinicalTrials.gov.