NCT00339144已完成1 期
A Phase I Study of BMS-354825 in Patients With Solid Tumors
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to Dasatinib Treatment
研究概览
简要总结
The primary objective of this study is to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
- •Histologic or cytologic diagnosis of a solid tumor which has progressed on or following standard therapies (including relapsed disease) or for which no standard therapy exists.
- •men and women, ages 20 and over
- •women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
- •Adequate hepatic function
排除标准
- •Participants who are eligible and willing to undergo transplantation at pre- study.
- •Women who are pregnant or breastfeeding with known brain metastasis or symptoms of brain metastasis
- •Uncontrolled or significant bleeding disorder unrelated to a primary tumor
- •Dementia or mental illness that would prohibit understanding or giving informed consent.
- •Severe allergy to drugs required for appropriate supportive care of patients in this study.
- •History of gastrointestinal surgery or of any digestive disorder which has the potential to inhibit absorption of the study drug.
- •Pleural effusion > Grade 1
- •Patient with dysphagia
- •Does not agree to blood/blood products transfusion(s)
- •Donated blood over 200 mL within 4 weeks prior to the start of study therapy
- •Medication that known to have a risk of causing Torsade de pointes
- •Participants who are compulsorily detained for legal reasons or 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
Dasatinib (100 mg)
Experimental
干预措施: Dasatinib (Drug)
Dasatinib (150 mg)
Experimental
干预措施: Dasatinib (Drug)
Dasatinib (200 mg)
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to Dasatinib Treatment
时间窗: From start of the treatment i.e.Day 1 to end of Cycle 1 i.e. Day 30 (4 weeks)
MAD: highest dose level at which \>=1 DLTs were reported, MTD: dose one step lower than MAD. DLT: any of the following considered related to dasatinib during course 1:Grade 3(dose reduction by 1 dose level)/Grade 4:recurring nausea, vomiting or diarrhea; any other Grade \>=3 non-hematologic toxicity except alopecia or fatigue;any grade toxicity requiring two dose reductions or participant's discontinuation; Grade 4 neutropenia \<500 cells/mm\^3 for \>=5 consecutive days or febrile neutropenia; Grade 4 thrombocytopenia \<25,000 cells/mm\^3 or Grade 3 bleeding requiring platelet transfusion.
次要结局
- Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs (SAEs), Drug Related AEs and Discontinued Due to AEs(From start of study drug therapy up to 30 days after the last dose.)
- Number of Participants With Grade 3 or 4 Hematology Abnormalities(From start of study drug therapy up to 30 days after the last dose.)
- Number of Participants With Grade 3-4 Serum Chemistry Abnormalities(From start of study drug therapy up to 30 days after the last dose.)
- Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=10% Participants: Low Lymphocyte Count(From start of study drug therapy up to 30 days after the last dose.)
- Most Frequent Serum Chemistry Laboratory Abnormalities Occurring in >=10% Participants: High Magnesium(From start of study drug therapy up to 30 days after the last dose.)
- Number of Participants With Clinically Meaningful Physical Examination Measures(From screening, Day 1 in each treatment course and at the end of study)
- Number of Participants With Clinically Meaningful Vital Signs(From screening, Day 1 , 8, 15 and 22 in the 1st treatment course, Day 8 and 22 in the second and subsequent courses and at the end of study)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings(From screening Day -1, and at pre-dose, 1 and 4 hours (post-dose) on Days 1, 14 and 28 in first treatment course, at pre-dose, 1 and 4 hours (post-dose) during the second and fourth week in subsequent courses and at the end of study)
- Number of Participants With Clinically Significant Change in QT Interval Corrected for Heart Rate (QTcF)(Baseline, Day 1, Day 14 and Day 28)
- Maximum Plasma Concentration (Cmax) of Dasatinib(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28)
- Area Under the Plasma-concentration-time Curve [AUC (INF)] of Dasatinib on Day 1(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Day 1)
- AUC[TAU] of Dasatinib(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28)
- Time to Reach Maximum Observed Plasma Concentration of Dasatinib (Tmax)(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28)
- Terminal Elimination Half-life (T-half) of Dasatinib(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28)
- Accumulation Index (AI) of Dasatinib(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28)
- Mean Apparent Oral Clearance (CLo) of Dasatinib(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28)
- Mean Apparent Volume of Distribution (Vz/F) of Dasatinib(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28)
- Cmax of Metabolite BMS-582691(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28)
- AUC (0-t) of Metabolite BMS-582691(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28)
- Tmax of the Metabolite BMS-582691(Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28)
- Mean Urine Concentration of Urinary N-telopeptide Type 1 Collagen (NTx) Biological Marker(Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28.)
- Mean Urine Concentration of Deoxypyridinoline (Dpyr) Biological Marker(Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6 12 and 24 hours post dose on Days 14 and 28)
- Mean Serum Concentration of Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP-5b) Biological Marker(Serum samples were assessed at baseline (Day -1) and on Days 14 and 28)
- Mean Serum Concentration of Bone Alkaline Phosphatase (BAP) Biological Marker(Serum samples were assessed on baseline (Day -1), and pre-dose on Days 14, 28)
- Number of Participants With Sarcoma (Src) and Phosphorylated Src (pSRc) Protein Expression in Peripheral Blood Mononuclear Cells (PBMC)(Plasma samples were collected on baseline (Day -1), 0 hour (pre-dose), 1 and 4 hours (post-dose) on Days 1, 14 and 28)
- Number of Participants With Complete Response (CR) or Partial Response (PR)(Within 4 weeks of first study drug administration, thereafter recorded every 4 or 8 weeks.)
研究者
研究点 (1)
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