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Phase I study of continuous MKC-1 in patients with advanced or metastatic solid malignancies using the modified Time-to-Event Continual Reassessment Method (TITE-CRM) dose escalation design

机译：使用改进的时间持续重新评估方法（Tite-CRM）剂量升级设计I期I研究患有先进或转移性固体恶性肿瘤的患者的连续MKC-1研究

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摘要

BackgroundMKC-1 is an oral cell-cycle inhibitor with broad antitumor activity in preclinical models. Clinical studies demonstrated modest antitumor activity using intermittent dosing schedule, however additional preclinical data suggested continuous dosing could be efficacious with additional effects against the mTor/AKT pathway. The primary objectives were to determine the maximum tolerated dose (MTD) and response of continuous MKC-1. Secondary objectives included characterizing the dose limiting toxicities (DLTs) and pharmacokinetics (PK).

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期刊名称 other
作者
Amye Tevaarwerk; George Wilding; Jens Eickhoff; Rick Chappell; Carolyn Sidor; Jamie Arnott; Howard Bailey; William Schelman; Glenn Liu;
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作者单位

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年(卷),期 -1(30),3
年度 -1
页码 1039–1045
总页数 14
原文格式 PDF
正文语种
中图分类
关键词
MKC-1 TITE-CRM Solid malignancy Novel dose escalation designs;

机译：MKC-1;TITE-CRM;实体恶性肿瘤;新型剂量递增设计;

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专利

1. Phase I study of continuous MKC-1 in patients with advanced or metastatic solid malignancies using the modified Time-to-Event Continual Reassessment Method (TITE-CRM) dose escalation design [J] . Amye Tevaarwerk, George Wilding, Jens Eickhoff, Investigational New Drugs . 2012,第3期

机译：使用改良的事件持续时间重新评估方法（TITE-CRM）剂量递增设计，对晚期或转移性实体恶性肿瘤患者进行连续MKC-1的I期研究
2. Phase I study of continuous MKC-1 in patients with advanced or metastatic solid malignancies using the modified Time-to-Event Continual Reassessment Method (TITE-CRM) dose escalation design. [J] . Amye Tevaarwerk, George Wilding, Jens Eickhoff, Investigational new drugs. . 2012,第3期

机译：使用改良的事件持续时间重新评估方法（TITE-CRM）剂量递增设计，对晚期或转移性实体恶性肿瘤患者进行连续MKC-1的I期研究。
3. Phase I dose-escalation study of cabazitaxel administered in combination with gemcitabine in patients with metastatic or unresectable advanced solid malignancies [J] . Rixe Olivier, Puzanov Igor, LoRusso Patricia M., Anti-cancer drugs . 2015,第7期

机译：卡巴他赛联合吉西他滨联合治疗转移性或不可切除的晚期实体恶性肿瘤患者的I期剂量递增研究
4. PHASE I DOSE-ESCALATING STUDY OF ELSAMITRUCIN IN DOGS WITH SPONTANEOUS MALIGNANCIES [C] . Sara Fiocchi, Kimberly Selting, Mona Rosenberg, Annual Conference of the Veterinary Cancer Society . 2009

机译：I期I剂量升级对具有自发恶性肿瘤的狗菌的升级研究
5. Two-stage continual reassessment method and patient heterogeneity for dose-finding studies. [D] . Jia, Xiaoyu. 2014

机译：两阶段连续重新评估方法和患者异质性用于剂量寻找研究。
6. Phase I dose-escalation study of cabazitaxel administered in combination with gemcitabine in patients with metastatic or unresectable advanced solid malignancies [O] . Olivier Rixe, Igor Puzanov, Patricia M. LoRusso, -1

机译：卡巴他赛联合吉西他滨治疗转移性或无法切除的晚期实体恶性肿瘤患者的I期剂量递增研究
7. Phase I study of continuous MKC-1 in patients with advanced or metastatic solid malignancies using the modified Time-to-Event Continual Reassessment Method (TITE-CRM) dose escalation design [O] . Amye Tevaarwerk, George Wilding, Jens Eickhoff, 2011

机译：使用改进的时间持续重新评估方法（Tite-CRM）剂量升级设计，I期I研究患有先进或转移性固体恶性肿瘤的患者的连续MKC-1研究

Phase I study of continuous MKC-1 in patients with advanced or metastatic solid malignancies using the modified Time-to-Event Continual Reassessment Method (TITE-CRM) dose escalation design

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