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Clinical Trials associated with Pegylated recombinant human endostatin(Simcere Pharmaceutical Group Ltd.)聚乙二醇化重组人血管内皮抑制素在晚期/转移性非小细胞肺癌或其他实体瘤的安全性、耐受性和药代动力学研究
[Translation] Safety, tolerability and pharmacokinetics of pegylated recombinant human endostatin in patients with advanced/metastatic non-small cell lung cancer or other solid tumors
主要目的:评价PEG-ENDO治疗晚期/转移性NSCLC或其他实体瘤的安全性、耐受性及药代动力学特征,确定PEG-ENDO联合化疗的后续临床试验推荐剂量。 次要目的:初步评价PEG-ENDO联合化疗在晚期/转移性NSCLC或其他实体瘤治疗中的临床疗效。
[Translation] Primary objective: To evaluate the safety, tolerability and pharmacokinetic characteristics of PEG-ENDO in the treatment of advanced/metastatic NSCLC or other solid tumors, and to determine the recommended dose for subsequent clinical trials of PEG-ENDO combined with chemotherapy. Secondary objective: To preliminarily evaluate the clinical efficacy of PEG-ENDO combined with chemotherapy in the treatment of advanced/metastatic NSCLC or other solid tumors.
A Phase Ⅰb Study Evaluating the Safety, Tolerability and Pharmacokinetics of Pegylated Recombinant Human Endostatin (PEG-ENDO) in Subjects With Advanced / Metastatic Non-small Cell Lung Cancer (NSCLC) or Other Solid Tumors
The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.
注射用聚乙二醇化重组人血管内皮抑制素在健康志愿者的单中心、开放、单次给药剂量递增的I期临床试验方案
[Translation] A single-center, open-label, single-dose escalation phase I clinical trial protocol for pegylated recombinant human endostatin for injection in healthy volunteers
研究健康志愿者对注射用聚乙二醇化重组人血管内皮抑制素单次给药的安全性、耐受性以及药代动力学参数,为后续临床试验制定给药方案提供依据。
[Translation] To study the safety, tolerability and pharmacokinetic parameters of a single dose of pegylated recombinant human endostatin for injection in healthy volunteers, and to provide a basis for formulating dosing regimens for subsequent clinical trials.
100 Clinical Results associated with Pegylated recombinant human endostatin(Simcere Pharmaceutical Group Ltd.)
100 Translational Medicine associated with Pegylated recombinant human endostatin(Simcere Pharmaceutical Group Ltd.)
100 Patents (Medical) associated with Pegylated recombinant human endostatin(Simcere Pharmaceutical Group Ltd.)
100 Deals associated with Pegylated recombinant human endostatin(Simcere Pharmaceutical Group Ltd.)