NCT01068483已完成1 期
A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies
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
- 107
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD) of BKM120
研究概览
简要总结
This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part.
Once the MTD has been defined, the MTD expansion part will be opened for enrollment.
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
- •All patients:
- •Histologically-confirmed advanced solid tumors
- •Progressive, recurrent unresectable disease
- •World Health Organization (WHO) Performance status ≤ 2
- •No history of primary brain tumor or brain metastases
- •MTD Expansion part:
- •Histologically-confirmed advanced solid tumors
- •Progressive, recurrent unresectable disease
- •World Health Organization (WHO) Performance status ≤ 2
- •No history of primary brain tumor; no brain metastases unless asymptomatic and clinically stable for ≥ 3 months
- •Patients with genetic or molecular alteration of the PI3K pathway
排除标准
- •Prior treatment with a PI3K inhibitor
- •History of or active major depressive episode, bipolar disorder, schizophrenia, or history of suicidal attempt or ideation
- •No clinically manifest diabetes mellitus (treated and/or with clinical signs)
- •No acute or chronic renal disease
- •No acute or chronic liver disease
- •No acute or chronic pancreatitis
- •No unresolved diarrhea
- •No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
- •No acute myocardial infarction or unstable angina pectoris within the past 3 months
- •Not pregnant or nursing and fertile patients must use barrier contraceptives
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BKM120
Experimental
Dose escalation followed by dose expansion
干预措施: BKM120 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of BKM120
时间窗: throughout the study
次要结局
- Pharmacokinetics of BKM120(throughout the study)
- Changes in tumor metabolic activity(throughout the study)
- Safety and tolerability of BKM120(throughout the study)
- Pharmacodynamics of BKM120(throughout the study)
- Clinical tumor response in patients with tumors that show PI3K pathway activation(throughout the study)
研究者
研究点 (2)
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