NL-OMON43009已完成不适用
A multicenter, open label, phase 1 dose escalation study to evaluate the pharmacokinetics, safety, and tolerability of INC280 tablet formulation with food in patients with cMET dysregulated advanced solid tumors - INC280 dose escalation food effect study in pts with cMET+ solid tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •* * 18 years of age.
- •* Cytopathologically or histolopathologically confirmed diagnosis of an advanced solid tumor harboring cMET dysregulation which has progressed despite standard therapy, or for which no standard therapy exists. See protocol page 30 for more details re cMET dysregulation.
- •* At least one measurable lesion.
- •* Adequate organ function. See protocol page 30-31 for more details.
- •* ECOG performance status (PS) of 0 or 1.
排除标准
- •* Prior treatment with crizotinib, or any other cMET or HGF inhibitor.
- •* Known hypersensitivity to any of the excipients of INC280.
- •* Symptomatic central nervous system metastases. See protocol page 31 for more details.
- •* Clinically significant, uncontrolled heart diseases, including QTcF * 450 ms (male patients), * 460 ms (female patients) on the screening ECG. See protocol page 31 for more details.
- •* Treatment with strong and moderate inhibitors of CYP3A4 or strong inducers of CYP3A4.
- •* Treatment with medications mentioned in items 13-15 on page 32.
- •* Pregnant or nursing (lactating) women.
- •* Females and males not using adequate contraception. See protocol page 32-33 for more details.
研究者
相似试验
已完成
不适用
A phase 1 multicenter, open label, dose-escalation study of oral LEE011 in patients with advanced solid tumors or lymphomas.cancerSolid tumors10027655NL-OMON39139ovartis20
终止
1 期
Intravenous APG-1387 administered to patients with advanced solid tumors and lymphomas to test for safety, tolerability and effect of APG-1387 on the body and how APG-1387 is processed by the human bodyadvanced solid tumorCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaCancer - Any cancerlymphomaACTRN12614000268640Jiangsu Ascentage Pharma Inc30
已完成
不适用
A phase I, multicenter, open-label dose escalation and expansion study of LOP628, administered intravenously in adult patients with cKit-positive tumors and acute myeloid leukemiaSmall Cell Lung cancerAcute Myeloide Leukemia10027655GISTNL-OMON42287ovartis15
已完成
不适用
A phase I, multicenter, open-label dose escalation study of LDK378, administered orally in adult patients with tumors characterized by genetic abnormalities in anaplastic lymphoma kinase(ALK)Tumors with genetic abnormality in ALK10027655NL-OMON36240ovartis4
已完成
不适用
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 malignanciesAdvanced and/or metastatic cancer10027655NL-OMON45230ovartis13