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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.KR |
First Approval Date15 Oct 2013 |
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MechanismTop II inhibitors |
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Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
注射用盐酸莎巴比星治疗难治或复发的小细胞肺癌(广泛期)安全性、耐受性及药代动力学Ⅰ期临床研究方案
[Translation] Phase I clinical study of safety, tolerability and pharmacokinetics of sabarubicin hydrochloride for injection in the treatment of refractory or relapsed small cell lung cancer (extensive stage)
主要目的:确定注射用盐酸莎巴比星治疗小细胞肺癌(广泛期)患者的最大耐受剂量及剂量限制性毒性,评价注射用盐酸莎巴比星治疗小细胞肺癌(广泛期)患者体内药代动力学特征。 次要目的:初步评价注射用盐酸莎巴比星治疗小细胞肺癌(广泛期)的有效性与安全性,为Ⅱ期临床研究推荐合理用药方案。
[Translation] Main purpose: To determine the maximum tolerated dose and dose-limiting toxicity of sabarubicin hydrochloride for injection in the treatment of patients with small cell lung cancer (extensive stage), and to evaluate the drug in vivo of sabarubicin hydrochloride for injection in patients with small cell lung cancer (extensive stage). Generation dynamics characteristics. Secondary objective: To preliminarily evaluate the efficacy and safety of sabarubicin hydrochloride for injection in the treatment of small cell lung cancer (extensive stage), and to recommend a rational drug regimen for phase II clinical research.
注射用盐酸莎巴比星联合顺铂治疗小细胞肺癌(广泛期)安全性、耐受性及药代动力学Ⅰ期临床研究
[Translation] Phase I clinical study of safety, tolerability and pharmacokinetics of sabarubicin hydrochloride for injection combined with cisplatin in the treatment of small cell lung cancer (extensive stage)
主要目的:确定注射用盐酸莎巴比星联合顺铂治疗小细胞肺癌(广泛期)患者的最大耐受剂量及剂量限制性毒性,评价注射用盐酸莎巴比星治疗小细胞肺癌患者体内药代动力学特征。
次要目的:初步评价注射用盐酸莎巴比星联合顺铂治疗小细胞肺癌(广泛期)的有效性与安全性,为Ⅱ期临床研究推荐合理给药方法。
[Translation] Main purpose: To determine the maximum tolerated dose and dose-limiting toxicity of sabarubicin hydrochloride for injection combined with cisplatin in the treatment of patients with small cell lung cancer (extensive stage), and to evaluate the in vivo pharmacokinetics of sabarubicin hydrochloride for injection in patients with small cell lung cancer (extensive stage). dynamic characteristics.
Secondary objective: To preliminarily evaluate the efficacy and safety of sabarubicin hydrochloride for injection combined with cisplatin in the treatment of small cell lung cancer (extensive stage), and to recommend reasonable dosing methods for phase II clinical studies.
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