A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
- Conditions
- Chronic myelogenous leukemia (CML)MedDRA version: 9.1Level: LLTClassification code 10009012Term: Chronic myelogenous leukemia
- Registration Number
- EUCTR2007-003780-50-FR
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 412
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone. ;Secondary Objective: Estimate the major molecular response (MMR) rate at one year.Estimate the duration of CCyR, CHR, and MMR.Estimate the time to transformation to accelerated phase (AP) and blast phase (BP).Assess the population PK of bosutinib.Assess comparative safety of bosutinib vs. imatinib;Primary end point(s): The primary endpoint for this study is the complete cytogenetic response (CCyR) rate at one year after randomization.
- Secondary Outcome Measures
Name Time Method