EUCTR2011-000083-10-BEActive, not recruitingNot Applicable
An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib plus Smoothen Antagonist (BMS-833923) in the Treatment of Subjects with Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CMLAmendment 05 - site specific (v1.0, dated 28-Jun-2012)Pharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 30-Mar-2011)Administrative Letter 01 dated 05-Jul-2011
Bristol-Myers Squibb International Corporation0 sites300 target enrollmentStarted: September 5, 2011Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Eligibility criteria are no longer applicable as all subjects are enrolled.
- •1. Subjects >= 18 years of age who have signed informed consent
- •2. Philadelphia positive chronic myeloid leukemia (CML) in chronic phase
- •3. Previously untreated
- •4. Performance status 0 - 2
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •Eligibility criteria are no longer applicable as all subjects are enrolled.
- •1. Known Abl-kinase T315I or T315A mutation
- •2. Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
- •3. Prior chemotherapy
- •4. Women who are pregnant or breastfeeding or WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period
Investigators
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