| Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML |
| A Phase 3 Randomized, Open-Label Study Of Bosutinib Versus Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Chronic Myeloid Leukemia |
- Drug: Bosutinib
500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
Other Name: SKI 606
- Drug: imatinib
400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
Other Name: Gleevec
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- Gambacorti-Passerini C, Cortes JE, Lipton JH, Dmoszynska A, Wong RS, Rossiev V, Pavlov D, Gogat Marchant K, Duvillié L, Khattry N, Kantarjian HM, Brümmendorf TH. Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. Am J Hematol. 2014 Oct;89(10):947-53. doi: 10.1002/ajh.23788. Epub 2014 Jul 21.
- Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10.
- Trask PC, Cella D, Powell C, Reisman A, Whiteley J, Kelly V. Health-related quality of life in chronic myeloid leukemia. Leuk Res. 2013 Jan;37(1):9-13. doi: 10.1016/j.leukres.2012.09.013. Epub 2012 Oct 29.
- Cortes JE, Kim DW, Kantarjian HM, Brümmendorf TH, Dyagil I, Griskevicius L, Malhotra H, Powell C, Gogat K, Countouriotis AM, Gambacorti-Passerini C. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol. 2012 Oct 1;30(28):3486-92. Epub 2012 Sep 4.
- O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317. Review. Erratum in: Nat Rev Cancer. 2012 Dec;12(12):886.
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| Completed |
| 502 |
| May 2015 |
| August 2010 (Final data collection date for primary outcome measure) |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- Exclusions include Philadelphia negative CML.
- Prior anti-leukemia treatment.
- Prior stem cell transplant.
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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| 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 |
| Croatia, Puerto Rico, Slovenia |
| |
| NCT00574873 |
3160A4-3000
B1871008 ( Other Identifier: Alias Study Number )
2007-003780-50 ( EudraCT Number ) |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer |
| August 2016 |
