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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
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MechanismEGFR T790M inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项评价甲磺酸哆希替尼片(90-1408)治疗有EGFR 突变阳性的局部晚期或转移性非小细胞肺癌患者的安全性、耐受性、药代动力学特征及初步疗效的剂量递增和剂量扩展的I 期/II 期临床研究
[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); 确定 90-1408治疗EGFR突变阳性的局部晚期或转移性NSCLC患者的 II期临床研究推荐剂量(RP2D);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; 探索90-1408 血浆、尿液中的药物代谢谱。
[Translation] Primary objective: 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 mutations. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of 90-1408 in the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations after single or multiple administrations; 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 determine the recommended dose (RP2D) of 90-1408 in the Phase II clinical study for 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 explore the drug metabolism profile of 90-1408 in plasma and urine.
100 Clinical Results associated with Henan Meitaibao Biopharmaceutical Co., Ltd.
0 Patents (Medical) associated with Henan Meitaibao Biopharmaceutical Co., Ltd.
100 Deals associated with Henan Meitaibao Biopharmaceutical Co., Ltd.
100 Translational Medicine associated with Henan Meitaibao Biopharmaceutical Co., Ltd.