EUCTR2011-000083-10-BE进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Eligibility criteria are no longer applicable as all subjects are enrolled.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
排除标准
- •Eligibility criteria are no longer applicable as all subjects are enrolled.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
研究者
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PH II DASATINIB COMBO w/ SMO INHIBITOR (BMS-833923)newly diagnosed Ph+ CP CMLMedDRA version: 14.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: LLTClassification code 10034877Term: Philadelphia chromosome positiveSystem Organ Class: 10022891 - InvestigationsEUCTR2011-000083-10-ESBristol-Myers Squibb International Corporation70
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