NCT01031628终止3 期
A Randomized, Phase 3 Study of Dose Escalation Versus No Dose Escalation of Imatinib In Metastatic GIST Patients With Imatinib Trough Levels Less Than 1100 Nanograms/mL
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 13
- 主要终点
- Evaluation of Lesions for Progression or Response Via RECIST Criteria
研究概览
简要总结
The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age ≥ 18 years
- •Unresectable and/or metastatic GIST
- •Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
- •For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
- •Good physical functioning (ECOG Performance Status of 0 or 1)
- •Generally, good function of organ such as liver and kidneys
排除标准
- •Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST)
- •Known intolerance of imatinib at a dose of 400 mg/day or higher
- •Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
- •Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
- •Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
- •Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks or who have not recovered from side effects of this therapy
研究组 & 干预措施
Arm A
Active Comparator
Patients with blood level less than 1100 will continue imatinib 400 mg daily
干预措施: Imatinib mesylate (Drug)
Arm B
Active Comparator
Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
干预措施: Imatinib mesylate (Drug)
Arm C
Active Comparator
Patients with blood level ≥1100 will continue imatinib 400 mg daily
干预措施: Imatinib mesylate (Drug)
Arm D
Active Comparator
Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
干预措施: Imatinib mesylate (Drug)
结局指标
主要结局
Evaluation of Lesions for Progression or Response Via RECIST Criteria
时间窗: Every 3 months
次要结局
未报告次要终点
研究者
研究点 (13)
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