A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To determine the MTD which will be the Phase II dose of AMN107 when given in combination with Imatinib. The MTD is defined to be the highest dose of AMN107 in combination with Imatinib given for at least 21 days in the first treatment cycle
研究概览
简要总结
This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.
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
- •Patients with gastrointestinal stromal tumor (GIST).
- •Patients who have had disease progression during imatinib therapy with 800 mg.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ.
- •A history of impaired cardiac function or uncontrolled cardiovascular disease.
- •Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN
- •Currently taking certain medications that could affect an electrocardiogram result.
- •Women who are pregnant or breast feeding.
- •Patients unwilling or unable to comply with the protocol.
- •NOTE: Additional inclusion and/ or exclusion criteria may apply.
研究组 & 干预措施
AMN107 + STI571
干预措施: AMN107, STI571 (Drug)
结局指标
主要结局
To determine the MTD which will be the Phase II dose of AMN107 when given in combination with Imatinib. The MTD is defined to be the highest dose of AMN107 in combination with Imatinib given for at least 21 days in the first treatment cycle
时间窗: From day 1 cycle 1 until at least six subjects have been treated at the recommended dose level and observed for at least 21 days
MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle
次要结局
- To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST(From day 1 cycle to the study completion visit)
- patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle)(up to 4 cycles after disease profression on imatinib)