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首页> 外文期刊>Investigational new drugs. >A phase I study of ispinesib, a kinesin spindle protein inhibitor, administered weekly for three consecutive weeks of a 28-day cycle in patients with solid tumors.
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A phase I study of ispinesib, a kinesin spindle protein inhibitor, administered weekly for three consecutive weeks of a 28-day cycle in patients with solid tumors.

机译：对Ispinesib（一种驱动蛋白纺锤体蛋白抑制剂）进行的I期研究在患有实体瘤的患者中连续28周每天连续3周，每周3次。

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PURPOSE: To establish the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), safety, and pharmacokinetic profile of ispinesib when administered as a 1-h intravenous infusion weekly for three consecutive weeks of a 28 day treatment period to patients with advanced solid tumors. EXPERIMENTAL DESIGN: Thirty patients were enrolled using an initial accelerated dose-escalation phase followed by a standard dose-escalation phase at doses ranging from 1-8 mg/m(2)/week. Pharmacokinetic samples, skin punch biopsies, and tumor biopsies (in patients with accessible tumor) were obtained during cycle 1 of treatment. Disease assessment was performed every two treatment cycles. RESULTS: The MTD was defined as 7 mg/m(2) administered as a 1-h infusion weekly for three consecutive weeks of a 28 day schedule. The MTD was exceeded at 8 mg/m(2) due to DLTs of grade 2 (one patient) and grade 3 neutropenia (one patient) that resulted in the inability to administer the Day 15 dose in Cycle 1. The neutrophil nadir occurred at approximately Day 8 with a 3-7 day recovery period. The most common toxicities were nausea, diarrhea, fatigue, and neutropenia. Alopecia, mucositis, and neuropathy were not observed. Stable disease was reported as the best response to treatment in nine patients. CONCLUSION: The recommended dose of ispinesib is 7 mg/m(2) over 1 h weekly for three consecutive weeks of a 28 day treatment cycle.
机译：目的：建立伊斯替尼的最大耐受剂量（MTD），剂量限制毒性（DLT），安全性和药代动力学特征，在28天的治疗期内连续三周每周1小时静脉输注给予伊西替尼晚期实体瘤。实验设计：30名患者采用最初的加速剂量递增阶段，随后是标准剂量递增阶段，剂量范围为1-8 mg / m（2）/周。在治疗的第一个周期中获得了药代动力学样本，皮肤穿孔活检和肿瘤活检（在可及肿瘤患者中）。每两个治疗周期进行一次疾病评估。结果：MTD定义为在28天的计划中连续三周每周1小时输注7 mg / m（2）。由于2级（一名患者）和3级中性粒细胞减少（一名患者）的DLT导致无法在第1周期中给予第15天剂量，因此MTD在8 mg / m（2）时被超过。大约第8天，恢复期为3-7天。最常见的毒性是恶心，腹泻，疲劳和中性粒细胞减少。未观察到脱发，粘膜炎和神经病。据报道，稳定的疾病是九名患者对治疗的最佳反应。结论：在为期28天的治疗周期中，连续3周每周1h的ispinesib推荐剂量为7 mg / m（2）。

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