NCT00101647已完成2 期
A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Major and Overall Hematologic Response (MaHR and OHR)
研究概览
简要总结
The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
- •Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not need to be their most recent CML treatment prior to coming on this study.
- •Men and women, 18 years of age or older.
- •Adequate hepatic function.
- •Adequate renal function.
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
排除标准
- •Women who are pregnant or breastfeeding.
- •Subjects who are eligible and willing to undergo transplantation during the screening period.
- •A serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy.
- •Uncontrolled or significant cardiovascular disease.
- •Medications that increase bleeding risk.
- •Medications that change heart rhythms.
- •Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- •History of significant bleeding disorder unrelated to CML.
- •Concurrent incurable malignancy other than CML.
- •Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
- •Prior therapy with dasatinib (BMS-354825).
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
研究组 & 干预措施
1
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
Major and Overall Hematologic Response (MaHR and OHR)
时间窗: Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment
MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4.
次要结局
- Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)(12 months)
- Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response)(24 months)
- Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months(12 months, 24 months)
- Median Time in Days From First Dosing Date to Date of MaHR(Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment)
- Time to OHR(Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment)
- Best Cytogenetic Response(Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment)
- Best Confirmed Hematologic Response(Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment)
- Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period(Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).)
- MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations(Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).)
- Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)(Baseline, every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up.(treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).)
- Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation(Continuous from pretreatment through each 4-week cycle and at follow-up. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).)
- Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)(Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.)
- Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 Hours (AUC[0-T])(Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.)
- Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)(Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.)
- Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)(Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.)
- Population PK of Dasatinib(Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.)
研究者
研究点 (1)
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