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Tasisulam-sodium 与 Paclitaxel 治疗转移性黑色素瘤的研究 (SUMMIT-1)

2018年6月18日 更新者：Eli Lilly and Company

一项在 28 天周期的第 1 天静脉输注他西素钠与紫杉醇作为转移性黑色素瘤患者二线治疗的随机 3 期研究

本研究的主要目的是通过总体存活率衡量，与紫杉醇相比，他西舒仑钠如何影响转移性黑色素瘤。

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

336

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Jerusalem、以色列、91120
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      • Tel Hashomer、以色列、52661
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      • Tel-Aviv、以色列、64239
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  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1Z2
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    • Ontario
      • Hamilton、Ontario、加拿大、L8V 5C2
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      • Toronto、Ontario、加拿大、M5G 2M9
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    • Quebec
      • Montreal、Quebec、加拿大、H3A 1A1
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  • 台湾
      • Changhua、台湾、500
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      • Niao Sung Hsiang、台湾、83301
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      • Taipei、台湾、100
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      • Tao-Yuan、台湾、333
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  • 大韩民国
      • Goyang-Si、大韩民国、411-764
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      • Seoul、大韩民国、110-744
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  • 奥地利
      • Graz、奥地利、8036
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      • Innsbruck、奥地利、6020
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      • Vienna、奥地利、A1090
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  • 德国
      • Berlin、德国、10117
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      • Buxtehude、德国、21614
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      • Essen、德国、D-45147
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      • Hannover、德国、30449
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      • Heilbronn、德国、D-74078
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      • Kiel、德国、24105
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      • Koeln、德国、50937
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      • Mainz、德国、55131
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      • Muenchen、德国、80337
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      • Muenster、德国、48157
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      • Quedlinburg、德国、06484
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      • Tuebingen、德国、72076
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  • 意大利
      • Genova、意大利、16132
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      • Milano、意大利、20141
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      • Napoli、意大利、80131
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      • Padova、意大利、35128
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      • Siena、意大利、53100
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  • 挪威
      • Oslo、挪威、0310
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      • Trondheim、挪威、7006
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  • 比利时
      • Antwerp、比利时、2020
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      • Brussels、比利时、1200
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      • Leuven、比利时、3000
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  • 法国
      • Bordeaux、法国、33075
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      • Dijon、法国、21034
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      • Grenoble、法国、38049
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      • Marseille、法国、13385
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      • Nantes、法国、44093
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      • Paris、法国、75475
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      • Toulouse、法国、31059
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      • Villejuif、法国、94805
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  • 波兰
      • Bialystok、波兰、15-027
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      • Gdansk、波兰、80-952
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      • Otwock、波兰、05-400
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      • Poznan、波兰、61-866
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  • 澳大利亚
    • New South Wales
      • Coffs Harbour、New South Wales、澳大利亚、2450
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      • Wollongong、New South Wales、澳大利亚、2500
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    • Queensland
      • Townsville、Queensland、澳大利亚、4810
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      • Woolloongabba、Queensland、澳大利亚、4102
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    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
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  • 瑞典
      • Malmo、瑞典、20502
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      • Stockholm、瑞典、11883
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  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35243
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    • Arizona
      • Scottsdale、Arizona、美国、85258
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      • Tucson、Arizona、美国、85724
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    • Arkansas
      • Little Rock、Arkansas、美国、72205
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    • California
      • Fresno、California、美国、93720
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      • Los Angeles、California、美国、90025
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      • San Francisco、California、美国、94115
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    • Florida
      • Fort Myers、Florida、美国、33916
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      • Jacksonville、Florida、美国、32207
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      • Lakeland、Florida、美国、33805
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      • Orlando、Florida、美国、32806
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      • West Palm Beach、Florida、美国、33401
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    • Georgia
      • Augusta、Georgia、美国、30901
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    • Illinois
      • Chicago、Illinois、美国、60611
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      • Park Ridge、Illinois、美国、60068
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    • Indiana
      • Goshen、Indiana、美国、46526
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      • Indianapolis、Indiana、美国、46260
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    • Iowa
      • Iowa City、Iowa、美国、52242
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    • Kansas
      • Westwood、Kansas、美国、66205
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      • Wichita、Kansas、美国、67214
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    • Kentucky
      • Louisville、Kentucky、美国、40402
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    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
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    • Minnesota
      • Minneapolis、Minnesota、美国、55455
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      • Rochester、Minnesota、美国、55905
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    • Missouri
      • Columbia、Missouri、美国、65203
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      • Saint Louis、Missouri、美国、63110
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    • Nebraska
      • Omaha、Nebraska、美国、68198
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    • Nevada
      • Las Vegas、Nevada、美国、89135
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    • New Jersey
      • Morristown、New Jersey、美国、07960
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    • North Carolina
      • Durham、North Carolina、美国、27710
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      • Winston-Salem、North Carolina、美国、27157
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    • North Dakota
      • Fargo、North Dakota、美国、58122
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    • Ohio
      • Cincinnati、Ohio、美国、45236
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      • Cleveland、Ohio、美国、44106
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      • Columbus、Ohio、美国、43219
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      • Toledo、Ohio、美国、43623
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    • Pennsylvania
      • Bethlehem、Pennsylvania、美国、18015
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      • Pittsburgh、Pennsylvania、美国、15232
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    • South Carolina
      • Charleston、South Carolina、美国、29425
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      • Columbia、South Carolina、美国、29210
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    • South Dakota
      • Rapid City、South Dakota、美国、57701
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    • Tennessee
      • Memphis、Tennessee、美国、38138
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      • Nashville、Tennessee、美国、37203
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    • Texas
      • Dallas、Texas、美国、75390
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      • La Porte、Texas、美国、77571
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      • The Woodlands、Texas、美国、77380
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    • Utah
      • Salt Lake City、Utah、美国、84106
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    • Virginia
      • Richmond、Virginia、美国、23230
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    • Washington
      • Seattle、Washington、美国、98109
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    • Wisconsin
      • Madison、Wisconsin、美国、53717
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  • 芬兰
      • Tampere、芬兰、33520
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      • Turku、芬兰、20520
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  • 英国
      • Manchester、英国、M20 4BX
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    • Cambridgeshire
      • Cambridge、Cambridgeshire、英国、CB2 0QQ
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Greater London
      • London、Greater London、英国、SW3 6JJ
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    • Hants
      • Southampton、Hants、英国、SO16 6YD
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    • London
      • Hampstead、London、英国、NW3 2QG
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Middlesex
      • Northwood、Middlesex、英国、HA6 2RN
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 荷兰
      • Leiden、荷兰、2300 RC
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Maastricht、荷兰、6229 HX
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      • Rotterdam、荷兰、3015 GD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 西班牙
      • Barcelona、西班牙、08036
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Madrid、西班牙、28046
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pamplona、西班牙、31008
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      • Valencia、西班牙、46014
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

纳入标准：

  • 具有转移性黑色素瘤（IV 期）的组织学和/或细胞学诊断。
  • 存在实体瘤反应评估标准 (RECIST 1.0) 所定义的可评估疾病。
  • 东部合作肿瘤组 (ECOG) 量表的表现状态为 0-1。
  • 在 1 次先前的含有达卡巴嗪或替莫唑胺的转移性黑色素瘤全身治疗后取得进展。
  • 已停止所有先前的癌症治疗，包括化学疗法、放射疗法、免疫疗法或其他研究性疗法至少 30 天（丝裂霉素 C 或亚硝基脲类药物为 6 周）并从治疗的急性效应中恢复（脱发除外）。
  • 血清白蛋白水平大于或等于 3.0 克每分升 (g/dL) 或大于或等于 30 克每升 (g/L)。

排除标准：

  • 已接受大于或等于 2 种先前的含化疗的转移性黑色素瘤全身治疗方案。 免疫疗法或基于抗体的治疗方案（包括生物制剂和基于疫苗的治疗），或靶向药物治疗（例如，BRAF 或 c-Kit 抑制剂不被视为确定研究资格的先前治疗方案，除非其中之一是与细胞毒性药物联合使用）。
  • 在进入研究时有活跃的中枢神经系统（CNS）或软脑膜转移（脑转移）。 有神经系统损害体征或症状的参与者应在进入研究前进行适当的放射成像，以排除隐匿性脑转移。 曾接受过治愈性治疗（例如，立体定向放射或手术）且不需要类固醇的孤立性 CNS 转移病史的参与者符合条件。
  • 正在接受华法林。
  • 患有原发性眼部或粘膜黑色素瘤。
  • 任何先前用紫杉醇或含紫杉醇的治疗方案治疗转移性黑色素瘤。
  • 患有与研究不相容的严重伴随疾病，包括活动性细菌、真菌或病毒感染（由研究者自行决定）。
  • 以前完成或退出本研究或任何其他研究他西苏兰钠的研究。
  • 已知对紫杉醇或 Cremophor EL（聚氧乙烯化蓖麻油）过敏。
  • 怀孕或哺乳期。
  • 最近（入组前 30 天内）或正在同时接受黄热病疫苗接种。
  • 已知人类免疫缺陷病毒 (HIV)、乙型肝炎表面抗原 (HBSAg) 或丙型肝炎抗体 (HCAb) 检测结果呈阳性。
  • 在用他西舒仑钠治疗前后至少 72 小时内无法停止服用非甾体类抗炎药 (NSAIDs) 或质子泵抑制剂 (PPIs)。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：他西苏兰钠
个体化的他磺胺钠剂量取决于参与者的身高、体重和性别。 根据实验室参数调整剂量。 在 28 天周期的第 1 天静脉内给予治疗，直至疾病进展。
药品：他西苏兰钠
在 28 天周期的第 1 天静脉内给药，直至疾病进展。
其他名称：
  • LY573636
有源比较器：紫杉醇
紫杉醇 80 毫克每平方米 (mg/m^2) 在 28 天周期的第 1、8 和 15 天静脉内给药，直至疾病进展
药品：紫杉醇
在 28 天周期的第 1、8 和 15 天静脉内给药 80 mg/m^2，直至疾病进展

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
总生存期（OS）
大体时间：随机化至任何原因死亡的日期（在每个周期和治疗停止后每 60 天进行评估）长达 14.32 个月
OS 是从入组到死亡的持续时间；操作系统对最后一次联系时还活着的参与者进行了审查。
随机化至任何原因死亡的日期（在每个周期和治疗停止后每 60 天进行评估）长达 14.32 个月

次要结果测量

结果测量
措施说明
大体时间
无进展生存期 (PFS)
大体时间：随机化至客观确定的 PD 或任何原因死亡的日期（在每个周期和治疗停止后每 60 天进行评估）长达 13.70 个月
PFS 是从第一次给药日期到第一次观察到疾病进展 (PD) 的时间； PD=靶病灶最长直径总和增加20%，或全因死亡。
随机化至客观确定的 PD 或任何原因死亡的日期（在每个周期和治疗停止后每 60 天进行评估）长达 13.70 个月
具有确认的部分响应 (PR) 或完全响应 (CR) 最佳响应的随机参与者的百分比
大体时间：达到 CR 或 PR（以先发生者为准）的首日 RECIST 标准，直至记录的 PD 或任何原因死亡（每隔一个周期评估一次）的首日，最长 13.70 个月
实体瘤反应评估标准 (RECIST) 标准：CR=所有目标病灶消失； PR=目标病灶最长直径总和减少30%；疾病进展 (PD) = 目标病灶最长直径总和增加 20%。
达到 CR 或 PR（以先发生者为准）的首日 RECIST 标准，直至记录的 PD 或任何原因死亡（每隔一个周期评估一次）的首日，最长 13.70 个月
具有部分反应 (PR) 或完全反应 (CR) 客观反应的参与者的反应持续时间 (DoR)
大体时间：达到 CR 或 PR（以先发生者为准）的首日 RECIST 标准，直至记录的 PD 或任何原因死亡（每隔一个周期评估一次）的首日，最长 13.70 个月
使用实体瘤反应评估标准 (RECIST) 标准的反应：CR=所有目标病变消失； PR=目标病灶最长直径总和减少30%；疾病进展 (PD) = 目标病灶最长直径总和增加 20%。 针对基线乳酸脱氢酶 (LDH) 调整了分析；疾病阶段；性别;既往单药免疫治疗；年龄阶层。 由于任一治疗组的反应数量有限，因此未进行 DoR 分析。
达到 CR 或 PR（以先发生者为准）的首日 RECIST 标准，直至记录的 PD 或任何原因死亡（每隔一个周期评估一次）的首日，最长 13.70 个月
确认最佳总体反应为部分反应 (PR) 或完全反应 (CR) 的随机参与者的百分比加上总体反应为稳定疾病 (SD) 的参与者
大体时间：达到 CR、PR 或 SD 的首日 RECIST 标准，直至记录到进展性疾病 (PD) 或任何原因死亡（每隔一个周期评估一次）的首日，最长 13.70 个月
使用实体瘤反应评估标准 (RECIST) 标准的反应：CR=所有目标病变消失； PR=目标病灶最长直径总和减少30%； SD=不符合上述标准的微小变化； PD=目标病灶最长直径之和增加20%。
达到 CR、PR 或 SD 的首日 RECIST 标准，直至记录到进展性疾病 (PD) 或任何原因死亡（每隔一个周期评估一次）的首日，最长 13.70 个月
癌症治疗功能评估恶化的时间-黑色素瘤试验结果指数 (FACT-M TOI) 评分
大体时间：随机化到 FACT-M TOI 恶化的第一天，或任何原因导致的死亡（每个周期和治疗停止后最多 30 天进行评估）长达 13.21 个月
FACT-M 测量与健康相关的生活质量 (HR-QoL) 的领域：身体健康、社会/家庭健康、情绪健康、功能健康和黑色素瘤的其他问题。 FACT-M TOI 是 FACT-M 身体健康、功能健康和黑色素瘤分量表的总和。 分数范围从 0 到 120；更高的分数 = 更好的生活质量 (QoL)。 FACT-M TOI 评分恶化定义为从随机化到 TOI 评分或死亡的最小重要差异的时间。
随机化到 FACT-M TOI 恶化的第一天，或任何原因导致的死亡（每个周期和治疗停止后最多 30 天进行评估）长达 13.21 个月
癌症治疗-黑色素瘤功能评估 (FACT-M) 在治疗停止后 30 天内从第 2 周期的基线变化
大体时间：第 2 周期的基线，治疗停止后最多 30 天
FACT-M 测量与健康相关的生活质量 (HR-QoL) 的领域：身体健康、社会/家庭健康、情绪健康、功能健康和黑色素瘤的其他问题。 总分范围从 0 到 172；更高的分数 = 更好的 HR-QoL。 最小二乘法 (LS) 平均值根据治疗组、周期、治疗与周期的交互作用、年龄、东部肿瘤协作组 (ECOG) 表现状态、研究开始时的疾病阶段以及对先前化疗的最佳反应进行调整。
第 2 周期的基线，治疗停止后最多 30 天
癌症治疗-黑色素瘤功能评估 (FACT-M) 从第 3 周期基线到治疗停止后 30 天的变化
大体时间：第 3 周期的基线，治疗停止后最多 30 天
FACT-M 测量与健康相关的生活质量 (HR-QoL) 的领域：身体健康、社会/家庭健康、情绪健康、功能健康和黑色素瘤的其他问题。 总分范围从 0 到 172；更高的分数 = 更好的 HR-QoL。 最小二乘法 (LS) 平均值根据治疗组、周期、治疗与周期的交互作用、年龄、东部肿瘤协作组 (ECOG) 表现状态、研究开始时的疾病阶段以及对先前化疗的最佳反应进行调整。
第 3 周期的基线，治疗停止后最多 30 天
癌症治疗-黑色素瘤 (FACT-M) 功能评估第 4 周期基线的变化，直至治疗停止后 30 天
大体时间：第 4 周期的基线，治疗停止后最多 30 天
FACT-M 测量与健康相关的生活质量 (HR-QoL) 的领域：身体健康、社会/家庭健康、情绪健康、功能健康和黑色素瘤的其他问题。 总分范围从 0 到 172；更高的分数 = 更好的 HR-QoL。 最小二乘法 (LS) 平均值根据治疗组、周期、治疗与周期的交互作用、年龄、东部肿瘤协作组 (ECOG) 表现状态、研究开始时的疾病阶段以及对先前化疗的最佳反应进行调整。
第 4 周期的基线，治疗停止后最多 30 天
EuroQol-5 维度 (EQ-5D) 从第 2 周期基线到治疗停止后 30 天的变化
大体时间：第 2 周期的基线，治疗停止后最多 30 天
EQ-5D 由评估参与者整体健康状况的 5 个项目组成。 参与者选择最能描述每个项目状态的 3 个选项中的 1 个。 基于 EQ-5D 英国 (UK) 的指数得分范围从 -0.59（最差健康）到 1.0（1.0=完美健康；相对于基线的积极变化=健康改善）。 最小二乘法 (LS) 平均值根据治疗组、周期、治疗与周期的交互作用、年龄、东部肿瘤协作组 (ECOG) 表现状态、研究开始时的疾病阶段以及对先前化疗的最佳反应进行调整。
第 2 周期的基线，治疗停止后最多 30 天
EuroQol-5 维度 (EQ-5D) 中从第 3 周期的基线到停止治疗后 30 天的变化
大体时间：第 3 周期的基线，治疗停止后最多 30 天
EQ-5D 由评估参与者整体健康状况的 5 个项目组成。 参与者选择最能描述每个项目状态的 3 个选项中的 1 个。 基于 EQ-5D 英国 (UK) 的指数得分范围从 -0.59（最差健康）到 1.0（1.0=完美健康；相对于基线的积极变化=健康改善）。 最小二乘法 (LS) 平均值根据治疗组、周期、治疗与周期的交互作用、年龄、东部肿瘤协作组 (ECOG) 表现状态、研究开始时的疾病阶段以及对先前化疗的最佳反应进行调整。
第 3 周期的基线，治疗停止后最多 30 天
EuroQol-5 维度 (EQ-5D) 中第 4 周期基线的基线在治疗停止后长达 30 天的变化
大体时间：第 4 周期的基线，治疗停止后最多 30 天
EQ-5D 由评估参与者整体健康状况的 5 个项目组成。 参与者选择最能描述每个项目状态的 3 个选项中的 1 个。 基于 EQ-5D 英国 (UK) 的指数得分范围从 -0.59（最差健康）到 1.0（1.0=完美健康；相对于基线的积极变化=健康改善）。 最小二乘法 (LS) 平均值根据治疗组、周期、治疗与周期的交互作用、年龄、东部肿瘤协作组 (ECOG) 表现状态、研究开始时的疾病阶段以及对先前化疗的最佳反应进行调整。
第 4 周期的基线，治疗停止后最多 30 天
药代动力学 (PK)：第 1 周期的最大血浆浓度 (Cmax)
大体时间：第 1 周期药物输注后（在 28 天周期内抽取 5 个样本）
第 1 周期药物输注后（在 28 天周期内抽取 5 个样本）
药代动力学：第 2 周期的最大血浆浓度 (Cmax)
大体时间：第 2 周期药物输注后（在 28 天周期内抽取 2 个样本）
第 2 周期药物输注后（在 28 天周期内抽取 2 个样本）

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年12月1日

初级完成 (实际的)

2011年3月1日

研究完成 (实际的)

2011年3月1日

研究注册日期

首次提交

2009年10月30日

首先提交符合 QC 标准的

2009年10月30日

首次发布 (估计)

2009年11月1日

研究记录更新

最后更新发布 (实际的)

2018年7月17日

上次提交的符合 QC 标准的更新

2018年6月18日

最后验证

2018年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 13101
  • H8K-MC-JZAO (其他标识符：Eli Lilly and Company)

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