EUCTR2007-003780-50-ES进行中（未招募）不适用
Estudio de fase 3, abierto y aleatorizado, de bosutinib comparado con imatinib en sujetos con leucemia mieloide crónica cromosoma Filadelfia positiva en fase crónica, de diagnóstico recienteA Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 412 人开始时间: 2008年2月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 412
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed for = 6 months.2. Adequate hepatic, and renal function.3. ECOG Performance status of 0 or 1.4. Age = 18 years.5. Recovered to = grade 1 or baseline from any toxicities of prior anti-cancer treatment.6. Negative serum pregnancy test within two weeks of the first dose of test article if the subject is a woman of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are eithersterile or using contraceptives.7. Willingness of all subjects who are not surgically sterile or postmenopausal to agree and commit to the use of a reliable method of birth control for the duration of the study and for 28 days after the last dose of test article.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Philadelphia chromosome negative CML.2. Prior anti-leukemia treatment. Up to 6 months of prior hydroxyurea or anagrelide treatment is allowed.3. Identified stem cell donor with transplant planned within 12 months of randomization.4. Prior stem cell transplant5. Central nervous system leukemia.6. Extramedullary disease only.7. History of accelerated or blast phase CML.8. Major surgery or radiotherapy within 14 days of randomization.9. Concomitant use of or need for medications known to prolong the QT interval.10. History of clinically significant or uncontrolled cardiac disease11. Known seropositivity to HIV, current acute or chronic hepatitis B (hepatitis B surface-antigen positive),hepatitis C, or cirrhosis.12. Recent or ongoing clinically significant gastrointestinal disorder13. Evidence of serious active infection or significant medical or psychiatric illness.
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