EUCTR2005-001294-99-IE进行中（未招募）不适用
A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects with Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who are Resistant or Intolerant to Imatinib Mesylate.Revised Protocol 06, incorporating Administrative Letters 01, 02, 03, 04 and 05 and Amendments 01, 02, 03, 04 and 05 (version 1.0, dated 14-Sep-2010)
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
- 400
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) Subjects with a myeloproliferative disorder defined as Ph+ (or BCR/ABL+) CP CML whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant to imatinib mesylate are eligible. Subjects can be pretreated with IFN, standard chemotherapy or high-dose chemotherapy and stem-cell transplantation.
- •Subjects considered to have Ph+ (or BCR/ABL+) CP CML must meet all the following
- •< 15% blasts in PB cells or BM
- •< 30% blasts + promyelocytes in PB cells or BM
- •< 20% basophils in PB cells
- •Platelets = 100,000/mm³ (or less if related to prior drug therapy)
- •No extra-medullar involvement (except liver or spleen)
- •Subjects with previous history of AP or BP CML and subjects with clonal evolution are not eligible even if they still meet the criteria for CP as defined above. They are considered in cytogenetic AP.
- •2) ECOG performance status (PS) score 0 - 2 (See Protocol Appendix 1)
- •3) Adequate hepatic function defined as:
- •total bilirubin = 2.0 times the institutional ULN
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- •= 2.5 times the institutional ULN
- •4) Adequate renal function defined as:
- •serum creatinine = 1.5 times the institutional ULN
- •5) Serum Na, K, Mg, P and total serum Ca or ionized Ca levels must be greater than
- •or equal to the institutional lower limit of normal. Subjects with low K, Mg levels,
- •total serum Ca and/or ionized Ca must be repleted to allow for protocol entry.
- •6) Men and women, 18 years of age and 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 one month before and for at least
- •3 months after completion of the study medication.
- •3) Women with a positive pregnancy test on enrollment or prior to study drug
- •administration.
- •4) Subjects eligible for immediate autologous or allogeneic stem cell transplantation.
- •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 (see Protocol section 5.2 for details)
- •7) History of significant bleeding disorder unrelated to CML
- •8) Clinically significant bleeding from the GI tract within 6 months
- •9) Concurrent incurable malignancy other than CML
- •10) Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- •11) Evidence of organ dysfunction or digestive dysfunction that would prevent
- •administration of study therapy
- •12) Subjects who received any of the following:
- •imatinib mesylate within 7 days
- •interferon or cytarabine within 7 days
- •a targeted small molecule anti-cancer agent within 7 days
- •any other investigational or any antineoplastic agent other than hydroxyurea (HU)
- •within 28 days
- •13) Subjects currently taking the following drugs that are generally accepted to have a risk of causing Torsades de Pointe (see Protocol section 5.2 for details)
- •14) Subjects who have discontinued any of these medications must have a wash-out
- •period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of BMS-354825.
- •15) Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
- •Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.
研究者
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