Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
NCT00574873
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- Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
- Diagnosis of CML chronic phase confirmed.
- Adequate hepatic and renal function.
- Able to take oral tablets.
- Exclusions include Philadelphia negative CML.
- Prior anti-leukemia treatment.
- Prior stem cell transplant.
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Descriptive Information | |||||||
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Brief Title ICMJE | Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML | ||||||
Official Title ICMJE | A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA | ||||||
Brief Summary | Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Chronic Myeloid Leukemia | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 502 | ||||||
Original Estimated Enrollment ICMJE | 412 | ||||||
Actual Study Completion Date ICMJE | May 27, 2015 | ||||||
Actual Primary Completion Date | August 31, 2010 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States | ||||||
Removed Location Countries | Croatia, Puerto Rico, Slovenia | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00574873 | ||||||
Other Study ID Numbers ICMJE | 3160A4-3000 B1871008 ( Other Identifier: Alias Study Number ) 2007-003780-50 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |