NCT01004224已完成1 期
A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, 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
- 208
- 试验地点
- 4
- 主要终点
- Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD)
研究概览
简要总结
The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.
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/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
- •Adequate bone marrow function
- •Adequate hepatic and renal function
- •Adequate cardiovascular function
- •Contraception.
- •For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
- •For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period
排除标准
- •Patients with primary CNS tumor or CNS tumor involvement
- •Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
- •History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
- •Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
- •History or current evidence of cardiac arrhythmia and/or conduction abnormality
- •Women who are pregnant or nursing.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BGJ398
Experimental
干预措施: BGJ398 (Drug)
结局指标
主要结局
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD)
时间窗: 23 months
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters
次要结局
- Assess preliminary anti-tumor activity for patients not in Arm 4.(23 months)
- To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations)(23 months)
- To determine the pharmacokinetic (PK) profiles of oral BGJ398(23 months)
- To evaluate the pharmacodynamic effect of the drug.(23 months)
研究者
研究点 (4)
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