A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
研究概览
简要总结
Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.
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
- •Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V)
- •Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month
- •Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease
- •Age ≥18 years
- •ECOG performance status of 0 or 1
- •Normal organ function
排除标准
- •Presence of PDGFRA D842V mutation
- •Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug
- •Concomitant anticoagulation with oral warfarin.
- •Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6
- •Uncontrolled intercurrent illness
- •Concurrent malignancy
研究组 & 干预措施
Imatinib TDM
Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.
干预措施: Imatinib (Drug)
结局指标
主要结局
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
时间窗: 6 months
To compare the incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 in patients who receive therapeutic drug monitoring (TDM) with imatinib to a historical control.
次要结局
- Percent of patients achieving therapeutic levels of imatinib.(6 months)
- Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years(3 year)
- Quality of Life based on the EORTC QLQ-C30(6 months)
研究者
Reema A. Patel
Assistant Professor
University of Kentucky