Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The rate of Complete Cytogenetic Response
研究概览
简要总结
This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce dasatinib dosage for adults with chronic myelogenous leukemia. Researchers will describe response rates and adverse events.
详细描述
Dasatinib is a second-generation tyrosine kinase inhibitor that is metabolized by the cytochrome P450. Dasatinib has shown efficacy in patients with chronic myelogenous leukemia. Standard-dose dasatinib is 50mg-140mg/day orally, continuously. However, when combined with a strong CYP3A4 inhibitor, a dose reduction of 75% is warranted.
This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce the dosage and costs of dasatinib for adults with chronic myelogenous leukemia. Researchers will describe cytogenetic and molecular response rates at 3, 6, and 12 months and adverse events (i.e., pleural effusion) associated with this strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age >18 years
- •Chronic myeloid leukemia in chronic phase according to the World Health Organization 2016
- •Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- •Chronic heart disease (NYHA III-IV)
- •Bleeding disorders not attributed to the hematological malignancy
- •Chronic myeloid leukemia in blast phase
- •Organic dysfunction (Marshall score ≥2)
研究组 & 干预措施
Dasatinib and ketoconazole
Patients will receive dasatinib at a dose of 25mg orally daily for one year and ketoconazole 200mg orally two times per day for one year.
干预措施: Dasatinib Pill (Drug)
Dasatinib and ketoconazole
Patients will receive dasatinib at a dose of 25mg orally daily for one year and ketoconazole 200mg orally two times per day for one year.
干预措施: Ketoconazole Pill (Drug)
结局指标
主要结局
The rate of Complete Cytogenetic Response
时间窗: Up to 6 months
B-cell antigen receptor(BCR)/Tyrosine-protein kinase-ABL1(ABL1) IS \<=1% at 6 months
次要结局
- The proportion of non hematological side effects(Up to 12 months)
- The rate of sustained Molecular Response (MR4.5)(Up to 12 months)
- The rate of Complete Cytogenetic Response(Up to 12 months)
- The rate of Molecular Response (MR4)(Up to 6 months)
- The rate of Molecular Response (MR4.5)(Up to 6 months)
研究者
David Gomez Almaguer
Head of Department
Hospital Universitario Dr. Jose E. Gonzalez