[Translation] A Phase I/II dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of doxitinib mesylate tablets (90-1408) in patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutations
主要目的:
评价甲磺酸哆希替尼片(90-1408)治疗EGFR 突变阳性的局部晚期或转移性非小细胞肺癌(NSCLC)患者的安全性和耐受性。
次要目的: 评价90-1408 治疗EGFR 突变阳性的局部晚期或转移性NSCLC 患者单次给药/多次给药的药代动力学(PK)特征;
确定90-1408 治疗EGFR 突变阳性的局部晚期或转移性NSCLC 患者的剂量限制性毒性(DLT)和最大耐受剂量(MTD);
评价90-1408 治疗EGFR 突变阳性的局部晚期或转移性NSCLC 患者的初步有效性;
评价90-1408 治疗T790M 突变阳性的局部晚期或转移性NSCLC 患者的初步有效性;
评价90-1408 治疗T790M 突变阳性的局部晚期或转移性NSCLC 患者的安全性;
探索90-1408 血浆、尿液中的药物代谢谱。
[Translation] Main purpose:
To evaluate the safety and tolerability of doxitinib mesylate tablets (90-1408) in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutation-positive.
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of single/multiple administration of 90-1408 in the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations;
To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of 90-1408 in the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations;
To evaluate the preliminary efficacy of 90-1408 in the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations;
To evaluate the preliminary efficacy of 90-1408 in the treatment of patients with locally advanced or metastatic NSCLC with T790M mutations;
To evaluate the safety of 90-1408 in the treatment of patients with locally advanced or metastatic NSCLC with T790M mutations;
To explore the drug metabolism profile of 90-1408 in plasma and urine.