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A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

2018年1月15日 更新者：Incyte Corporation

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer

This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.

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)

149

阶段

  • 阶段2

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

  • 意大利
      • Alba、意大利
      • Fano、意大利
      • Foggia、意大利
      • Lecco、意大利
      • Milano、意大利
      • Naples、意大利
      • Pontedera、意大利
      • Roma、意大利
      • Saronno、意大利
  • 法国
      • La Roche Sur Yon、法国
      • Paris、法国
      • Paris Cedex 10、法国
  • 美国
    • Alabama
      • Birmingham、Alabama、美国
    • Arizona
      • Chandler、Arizona、美国
      • Sedona、Arizona、美国
    • California
      • La Jolla、California、美国
      • Los Angeles、California、美国
      • Oxnard、California、美国
      • San Diego、California、美国
      • San Francisco、California、美国
      • Santa Monica、California、美国
    • Colorado
      • Aurora、Colorado、美国
      • Denver、Colorado、美国
    • Connecticut
      • New Haven、Connecticut、美国
    • District of Columbia
      • Washington、District of Columbia、美国
    • Florida
      • Fort Myers、Florida、美国
      • Hialeah、Florida、美国
      • Miami、Florida、美国
      • Plantation、Florida、美国
      • Saint Petersburg、Florida、美国
      • Tampa、Florida、美国
    • Georgia
      • Atlanta、Georgia、美国
      • Marietta、Georgia、美国
      • Savannah、Georgia、美国
    • Illinois
      • Chicago、Illinois、美国
      • Quincy、Illinois、美国
      • Springfield、Illinois、美国
      • Urbana、Illinois、美国
    • Iowa
      • Ames、Iowa、美国
    • Kansas
      • Wichita、Kansas、美国
    • Kentucky
      • Louisville、Kentucky、美国
    • Louisiana
      • Baton Rouge、Louisiana、美国
    • Maryland
      • Baltimore、Maryland、美国
    • Michigan
      • Detroit、Michigan、美国
      • Kalamazoo、Michigan、美国
    • Minnesota
      • Duluth、Minnesota、美国
      • Minneapolis、Minnesota、美国
    • Missouri
      • Kansas City、Missouri、美国
      • Saint Louis、Missouri、美国
    • Nebraska
      • Grand Island、Nebraska、美国
      • Omaha、Nebraska、美国
    • New Jersey
      • Camden、New Jersey、美国
      • Hackensack、New Jersey、美国
    • New Mexico
      • Farmington、New Mexico、美国
    • New York
      • Albany、New York、美国
      • Bronx、New York、美国
      • Johnson City、New York、美国
      • New York、New York、美国
    • North Carolina
      • Goldsboro、North Carolina、美国
      • Pinehurst、North Carolina、美国
    • Ohio
      • Canton、Ohio、美国
      • Cincinnati、Ohio、美国
      • Cleveland、Ohio、美国
      • Columbus、Ohio、美国
      • Middletown、Ohio、美国
    • Oregon
      • Portland、Oregon、美国
    • Pennsylvania
      • Bethlehem、Pennsylvania、美国
      • Philadelphia、Pennsylvania、美国
      • Pittsburgh、Pennsylvania、美国
    • South Carolina
      • Charleston、South Carolina、美国
      • Greenville、South Carolina、美国
    • Tennessee
      • Chattanooga、Tennessee、美国
      • Germantown、Tennessee、美国
      • Nashville、Tennessee、美国
    • Texas
      • Arlington、Texas、美国
      • Bedford、Texas、美国
      • Dallas、Texas、美国
      • El Paso、Texas、美国
      • Fort Worth、Texas、美国
      • Houston、Texas、美国
      • McAllen、Texas、美国
      • Plano、Texas、美国
      • Tyler、Texas、美国
    • Utah
      • Ogden、Utah、美国
      • Salt Lake City、Utah、美国
    • Virginia
      • Fairfax、Virginia、美国
      • Norfolk、Virginia、美国
      • Richmond、Virginia、美国
      • Salem、Virginia、美国
    • Washington
      • Seattle、Washington、美国
    • Wisconsin
      • Green Bay、Wisconsin、美国
      • Milwaukee、Wisconsin、美国
  • 英国
      • Cardiff、英国
      • Glasgow、英国
      • Kingston Upon Thames、英国
      • London、英国
      • Nottingham、英国
      • Sutton、英国
      • Taunton、英国
      • Truro、英国
      • Yeovil、英国
  • 葡萄牙
      • Lisbon、葡萄牙
  • 西班牙
      • A Coruña、西班牙
      • Barcelona、西班牙
      • Jaén、西班牙
      • Lleida、西班牙
      • Madrid、西班牙

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

女性

描述

Inclusion Criteria:

  • Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
  • Locally advanced (Stage 3B) or metastatic (Stage 4) disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
  • Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
  • ≥ 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
  • Radiographically measurable or evaluable disease

  • An mGPS of 1 or 2 as defined below:

    • Criteria:

      1. modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
      2. mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L

Exclusion Criteria:

  • Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
  • Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
  • Unknown hormone-receptor status
  • Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
  • Concurrent anticancer therapy
  • Inadequate renal, hepatic or bone marrow function
  • Another current or previous malignancy within 2 years of study entry unless approved by the sponsor

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment A - Capecitabine and ruxolitinib
药品：Ruxolitinib

5 mg tablets to be administered by mouth

Ruxolitinib 15 mg BID (starting dose)

其他名称：
  • 加卡菲®
  • 加卡维®
药品：Capecitabine
Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle
有源比较器：Treatment B - Capecitabine and placebo
药品：Capecitabine
Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle
药品：安慰剂
5 mg 匹配的安慰剂药片，口服

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
Overall Survival (OS)
大体时间：Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Median Survival
大体时间：Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Percentage of Participants Achieving Overall Survival
大体时间：Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.

次要结果测量

结果测量
措施说明
大体时间
Progression-free Survival (PFS)
大体时间：Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.
Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
Percentage of Participants Achieving Objective Response Rate
大体时间：Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Duration of Response (DOR)
大体时间：Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Percentage of Participants Achieving Clinical Benefit Rate
大体时间：Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

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

Incyte Corporation

调查人员

  • 研究主任：Gerard Kennealey, MD、Incyte Corporation

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)

2014年5月1日

初级完成 (实际的)

2016年2月1日

研究完成 (实际的)

2017年1月1日

研究注册日期

首次提交

2014年4月18日

首先提交符合 QC 标准的

2014年4月18日

首次发布 (估计)

2014年4月22日

研究记录更新

最后更新发布 (实际的)

2018年2月13日

上次提交的符合 QC 标准的更新

2018年1月15日

最后验证

2018年1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

  • INCB 18424-268

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.

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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