A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
2021年7月28日 更新者：AbbVie
An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
This is a Japanese, multicenter, open-label, dose-escalation study.
This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).
研究概览
研究类型
介入性
注册 (实际的)
29
阶段
- 阶段1
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
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Wakayama、日本、641-8510
- Wakayama Medical University /ID# 161428
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Chiba
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Kashiwa-shi、Chiba、日本、277-8577
- National Cancer Ctr Hosp East /ID# 161432
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Fukuoka
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Fukuoka-shi、Fukuoka、日本、812-8582
- Kyushu University Hospital /ID# 161430
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Osaka
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Osakasayama-shi、Osaka、日本、589-8511
- Kinki University -Osakasayama Campus /ID# 161431
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Tokyo
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Chuo-ku、Tokyo、日本、104-0045
- National Cancer Center Hospital /ID# 161429
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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
20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
Inclusion Criteria:
- Histologically or cytologically confirmed advanced, recurrent small-cell lung cancer (SCLC) with documented disease progression after at least two (2) prior systemic regimens, including at least one (1) platinum-based regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic and renal function.
Exclusion Criteria:
- No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.
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：非随机化
- 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 |
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实验性的：Part A: Rovalpituzumab tesirine
Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle
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静脉
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实验性的：Part B: Rovalpituzumab tesirine
Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD).
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静脉
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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 |
|---|---|---|
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Number of participants with dose-limiting toxicities (DLT)
大体时间：Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)
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DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
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Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Duration of response (DOR)
大体时间：First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
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First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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Objective Response Rate (ORR)
大体时间：First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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Overall survival (OS)
大体时间：First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.
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OS is defined as the time from the date of first dose to the date of death.
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First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.
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Progression-free survival (PFS)
大体时间：First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first.
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First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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Clinical benefit rate (CBR)
大体时间：First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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CBR is defined as the proportion of participants whose overall response is either CR, PR, or Stable Disease (SD) according to RECIST version 1.1.
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First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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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
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Udagawa H, Akamatsu H, Tanaka K, Takeda M, Kanda S, Kirita K, Teraoka S, Nakagawa K, Fujiwara Y, Yasuda I, Okubo S, Shintani M, Kosloski MP, Scripture C, Tamura T, Okamoto I. Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancer. Lung Cancer. 2019 Sep;135:145-150. doi: 10.1016/j.lungcan.2019.07.025. Epub 2019 Jul 24.
- Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.
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 (实际的)
2017年4月28日
初级完成 (实际的)
2018年1月30日
研究完成 (实际的)
2018年8月20日
研究注册日期
首次提交
2017年3月17日
首先提交符合 QC 标准的
2017年3月17日
首次发布 (实际的)
2017年3月22日
研究记录更新
最后更新发布 (实际的)
2021年8月3日
上次提交的符合 QC 标准的更新
2021年7月28日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.