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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 pharmacokinetics 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 the dose escalation test, it was observed that the single drug of this product was administered by intravenous infusion for 30 minutes once a week for 2 weeks, with a rest of 1 week, and every 3 weeks was a treatment cycle. The DLT and MTD of patients with advanced solid tumors, Recommend reasonable dosing schedule and basis for Phase II clinical study; 2. Observing the pharmacokinetics (PK) characteristics of intravenous administration of this product. 3. Observe the frequency, duration and reversibility of adverse reactions of this product under the established dosing regimen. 4. Preliminary evaluation of the efficacy of this product in patients with advanced solid tumors.
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