NCT01859351终止1 期
A Phase I Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the PI3K Inhibitor WX-037, Given as a Single Agent and in Combination With the MEK Inhibitor WX-554, in Patients With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Incidence of Dose limiting toxicities
研究概览
简要总结
The purpose of this study is to test the safety of escalating doses of the novel PI3K inhibitor WX-037 and to explore its effectiveness in combination with WX-554 which targets mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these two novel compounds could provide targeted inhibition of both pathways to block tumour growth.
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 advanced, metastatic and/or progressive solid tumors for whom there is no effective standard therapy available (for part 2 in addition patients for whom their PI3K pathway is deregulated)
- •Evaluable or measurable disease
- •Has normal organ function; is no greater than 2 on the ECOG performance scale
- •Negative hCG test in women of childbearing potential
排除标准
- •History of diabetes requiring daily medication or history of grade 3 or more fasting hyperglycemia
- •Patients with major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study
- •Clinical significant, unresolved toxicity from previous anti-cancer therapy
- •Patients who previously received a MEK inhibitor (for combination part only)
- •Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs
- •Known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm Hg or patient considered at risk of retinal vein thrombosis (combination part only)
- •Known HIV positivity or active hepatitis B or C infection
- •History of clinically significant cardiac condition
研究组 & 干预措施
WX-037
Experimental
PI3K inhibitor
干预措施: WX-037 (Drug)
WX-037 in combination with WX-554
Experimental
PI3K inhibitor in combination with MEK inhibitor
干预措施: WX-037 (Drug)
WX-037 in combination with WX-554
Experimental
PI3K inhibitor in combination with MEK inhibitor
干预措施: WX-554 (Drug)
结局指标
主要结局
Incidence of Dose limiting toxicities
时间窗: during cycle 1 (21days) of treatment with WX-037
Incidence of Dose Limiting toxicities
时间窗: during cycle 1 (21 days) of treatment with WX-037 and WX-554
次要结局
- Number of patients with adverse Events and serious adverse events(from cycle 1 day 1 until treatment discontinuation, an estimated average of 18 weeks)
- Assessment of PK variables, peak plasma concentration (Cmax), area under the curve (AUC)(two PK profiles in cycle 1)
- Determination of PD markers; changes from baseline in biomarkers of pathway inhibition(predose until treatment discontinuation, an estimated average of 18 weeks)
研究者
研究点 (3)
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