NCT01387321已完成1 期
A Study of BYL719 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
- 33
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
In this study, BYL719 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 investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with histologically-confirmed, advanced unresectable solid tumors Availability of a representative formalin fixed paraffin embedded tumor tissue sample
- •At least one measurable or non-measurable lesion Age ≥ 18 years
- •Eastern Cooperative Oncology Group(ECOG) Performance Status ≤ 2 Good organ (hepatic, kidney, BM) function at screening/baseline visit
排除标准
- •Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
- •Prior treatment with PI3K inhibitor
- •Patient with peripheral neuropathy NCI-CTC Grade ≥ 2
- •Patient with diarrhea NCI-CTC Grade ≥ 2
- •Patient with acute or chronic pancreatitis
- •Impaired cardiac function or clinically significant cardiac disease incl unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug
- •Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus
- •Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BYL719
Experimental
干预措施: BYL719 (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 4 Weeks
次要结局
- Efficacy assessed by RECIST(4 months)
- Safety assessed by type, frequency and severity of adverse events(4 Months)
- To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2)(4 months)
- Levels of biomarkers in tumor and skin(4 months)
研究者
研究点 (1)
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