EUCTR2004-002601-69-BE进行中（未招募）不适用
A Phase II Study to Determine the Activity of BMS-354825 in Subjects with ChronicPhase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who HaveDisease that is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who areIntolerant of ImatinibRevised Protocol 01 version 4.0, incorporating Amendment 02 and Administrative Letter dated 01-Mar-2005, and Amendment 01 version 2.0 dated 28-Apr-2005
适应症
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
- 250
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
- •1) Available for periodic follow-up
- •2) Life expectancy of at least approximately 3 months
- •3) ECOG performance status score 0-1
- •4) Subjects with chronic phase Ph+ CML, defined as a myeloproliferative disorder with evidence of a Philadelphia chromosome on cytogenetic analysis. Subjects meeting all of the following criteria will be classified as having chronic phase CML:
- •< 15% blasts in peripheral blood and in bone marrow
- •< 20% basophils in peripheral blood
- •< 30% blasts + promyelocytes in peripheral blood and in bone marrow
- •Platelets = 100,000/mm3 unless thrombocytopenia is due to recent therapy
- •No extramedullary involvement (other than liver or spleen)
- •5) Subjects must fulfill at least one of the following criteria relating to prior treatment
- •with imatinib:
- •A. Previously been treated with imatinib at a dose of > 600 mg/day AND developed
- •progressive disease while receiving imatinib at that dose.
- •B. CML with resistance to imatinib =600 mg/d with genetic mutation in the BCR-ABL
- •gene that is associated with a high level of resistance to imatinib.
- •C. Intolerant of imatinib at any dose.
- •6) Adequate hepatic function defined as:
- •total bilirubin = 2.0 times the institutional upper limit of normal
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =
- •2.5 times the institutional upper limit of normal
- •7) Adequate renal function defined as:
- •serum creatinine = 1.5 times the institutional upper normal limit
- •8) Serum potassium and magnesium levels within institutional normal limits. Total
- •serum calcium or ionized calcium level must be greater than or equal to the lower
- •limit of normal.
- •9) Men and women, ages 18 years of age or older.
- •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) Women who are pregnant or breastfeeding.
- •2) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period of at least 1 month before and at least 3 months
- •after completion of the study medication.
- •3) Previous diagnosis of accelerated phase or blast crisis CML
- •4) Subjects who are eligible and willing to undergo transplantation during the screening period
- •5) A serious uncontrolled medical disorder or active infection that would impair the
- •ability of the subject to receive protocol therapy.
- •6) Uncontrolled or significant cardiovascular disease
- •7) History of significant bleeding disorder unrelated to CML,
- •8) Concurrent incurable malignancy other than CML.
- •9) Evidence of organ dysfunction or digestive dysfunction that would prevent
- •administration of study therapy
- •10) Subjects who received
- •a) imatinib within 7 days
- •b) interferon or cytarabine within 14 days
- •c) a targeted small molecule anti-cancer agent within 14 days,
- •d) any other investigational or antineoplastic agent other than hydroxyurea within 4 weeks before starting treatment with BMS-354825
- •11) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsade de Pointes.
- •12) Subjects taking medications that irreversibly inhibit platelet function
- •13) Subjects taking medications known to be potent CYP3A4 inhibitors or inducers
- •14) Prior therapy with BMS-354825.
研究者
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