NCT01283503已完成1 期
A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- establish Maximum tolerate dose (MTD)
研究概览
简要总结
In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
- •At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors.
- •Age ≥ 20 years
- •Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
- •Life expectancy of ≥ 12 weeks
- •Patients must have the laboratory values
排除标准
- •Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- •Prior treatment with a PI3K inhibitor
- •Patients with any peripheral neuropathy ≥ CTCAE grade 2
- •Patients with unresolved diarrhea ≥ CTCAE grade 2
- •Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BKM120
Experimental
干预措施: BKM120 (Drug)
结局指标
主要结局
establish Maximum tolerate dose (MTD)
时间窗: every day up to first 4 weeks
次要结局
- Efficacy assessed by RECIST(Every 2 months)
- Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples(Every 2 weeks up to first 4 weeks, then every odd cycle)
- Measurement of biomarkers for PI3K pathway in blood and tissue(First 4 weeks)
- Safety assessed by type, frequency and severity of adverse events(Every week)
研究者
研究点 (1)
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