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MechanismDNA-directed DNA polymerase inhibitors |
Active Org.- |
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Active Indication- |
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Drug Highest PhaseDiscontinued |
First Approval Ctry. / Loc.- |
First Approval Date- |
曲沙他滨(Troxacitabine)注射液 用于晚期实体瘤患者的Ⅰ期临床耐受性及药代动力学研究
[Translation] Phase I clinical tolerability and pharmacokinetic study of troxacitabine injection in patients with advanced solid tumors
1.通过剂量递增试验,观察本品单药每周给药1次静脉滴注30分钟,连用2周,休息1周,每3周为一个治疗周期,对晚期实体瘤患者的DLT和MTD,为Ⅱ期临床研究推荐合理的给药方案和依据; 2.观察本品静脉给药的药代动力学(PK)特征。 3.观察本品在既定给药方案下的不良反应发生频率、持续时间和可逆性。 4.初步评价本品对晚期实体瘤患者的有效性。
[Translation] 1. Through a dose escalation trial, observe the DLT and MTD of this product for patients with advanced solid tumors when the product is administered once a week by intravenous drip for 30 minutes, used for 2 consecutive weeks, and rested for 1 week, with each 3-week treatment cycle, so as to recommend a reasonable dosing regimen and basis for Phase II clinical studies; 2. Observe the pharmacokinetic (PK) characteristics of this product when administered intravenously. 3. Observe the frequency, duration and reversibility of adverse reactions of this product under the established dosing regimen. 4. Preliminary evaluation of the effectiveness of this product in patients with advanced solid tumors.
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