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A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

2018年6月27日 更新者：Puma Biotechnology, Inc.

A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer

The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

110

阶段

  • 阶段2
  • 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

  • 中国
      • Beijing、中国、100021
        • Cancer Hospital, Chinese Academy of Medical Sciences
      • Beijing、中国、100032
        • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
    • Beijing
      • Beijing、Beijing、中国、100071
        • The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
      • Beijing、Beijing、中国、100853
        • Chinese People's Liberation Army General Hospital
    • Tianjin
      • TianJin、Tianjin、中国、300060
        • Tianjin Cancer Hospital
      • Tianjin、Tianjin、中国、300121
        • Tianjin Union Medicine Center Department of Oncology
  • 乌克兰
      • Dnipropetrovsk、乌克兰、49102
        • City Multifield Clinical Hospital #4 Department of chemotherapy, Dnipropetrovs'k State Medical Academy, Chair of Oncology and Medical Radiology
      • Lviv、乌克兰、79031
        • State Oncological Regional Treatment and Diagnostic Center Department of chemotherapy
  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2M9
        • Princess Margaret Hospital University Health Network
  • 印度
    • Maharashtra
      • Pune、Maharashtra、印度、411001
        • Jehangir Clinical Development Centre, Jehangir Hospital Premises
      • Pune、Maharashtra、印度、411004
        • M.M.F. Joshi Hospital & Ratna Memorial Hospital
    • Parel
      • Mumbai、Parel、印度、400012
        • Tata Memorial Hospital
    • Rajasthan
      • Jaipur、Rajasthan、印度、302004
        • Birla Cancer Centre, S.M.S. Medical College & Hospital
  • 大韩民国
      • Seoul、大韩民国、120-752
        • Yonsei University Health System - Severance Hospital
      • Seoul、大韩民国、138-736
        • Asan Medical Center, Division of Oncology, Department of Internal Medicine
  • 比利时
      • Brussels、比利时、1000
        • Institut Jules Bordet Unite du Chimiotherapie
      • Gent、比利时、9000
        • Universitair Ziekenhuis Gent
      • Kortrijk、比利时、8500
        • AZ Groeninge Campus Maria's Voorzienigheid (MV)
      • Wilrijk、比利时、2610
        • Oncologisch Centrum GZA - Location St Augustinus
  • 波兰
      • Krakow、波兰、31-826
        • Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera, Oddzial Onkologii
      • Lublin、波兰、20-090
        • Oddzial Chemioterapii Centrum Onkologii Ziemii Lubelskiej
  • 美国
    • California
      • La Jolla、California、美国、92093
        • Moores UC San Diego Cancer Center
      • La Jolla、California、美国、92037
        • Scripps, Clinic General
      • San Diego、California、美国、92123
        • Sharp Memorial Hospital
    • Massachusetts
      • Boston、Massachusetts、美国、02118
        • Boston University Medical Center
    • Michigan
      • Lansing、Michigan、美国、48912
        • Mid-Michigan Physicians-HOS Division
      • Saint Joseph、Michigan、美国、49085
        • Oncology Care Associates
    • New York
      • New York、New York、美国、10032
        • Columbia University Medical Center
    • Texas
      • San Antonio、Texas、美国、78229
        • CTRC at The University of Texas Health Science Center
  • 香港
      • Hong Kong、香港
        • Department of Medicine, Queen Mary Hospital
      • Hong Kong、香港
        • UNIMED Medical Institute
      • Hong Kong、香港
        • Department of Surgery Queen Mary Hospital

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

Inclusion Criteria:

Inclusion criteria for both parts of clinical trial:

  • Good performance status
  • Normal ejection fraction
  • Adequate cardiac, kidney, and liver function
  • Adequate blood counts
  • At least one measurable target lesion
  • Negative pregnancy test for female subjects

Inclusion Criteria for Part 1 Only:

- Pathologically confirmed solid tumor not curable with available standard therapy

Inclusion Criteria for Part 2 Only:

  • Pathologically confirmed breast cancer
  • HER2 positive tumor
  • Prior treatment with Herceptin

Exclusion Criteria:

Exclusion criteria for both parts of clinical trial:

  • Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1
  • Subjects with bone or skin as the only site of disease
  • Active central nervous system metastases
  • Significant cardiac disease or dysfunction
  • Significant gastrointestinal disorder
  • Inability or unwillingness to swallow HKI-272 capsules
  • Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.
  • Treatment with a taxane within 3 months of treatment day 1
  • Grade 2 or greater motor or sensory neuropathy
  • Pregnant or breast feeding women
  • Known hypersensitivity to paclitaxel or Cremophor EL
  • Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
  • Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin

Exclusion Criteria for Part 2 Only:

- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease

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
实验性的：HKI-272 dose level 1
Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 160 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
药品：紫杉醇
药品：HKI-272
其他名称：
  • 来那替尼
实验性的：HKI-272 dose level 2
Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
药品：紫杉醇
药品：HKI-272
其他名称：
  • 来那替尼
实验性的：HKI-272 expanded MTD cohort, arm A
Part 2: Subjects with metastatic breast cancer who have not received more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
药品：紫杉醇
药品：HKI-272
其他名称：
  • 来那替尼
实验性的：HKI-272 expanded MTD cohort, arm B
Part 2: Subjects with metastatic breast cancer who have not received more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
药品：紫杉醇
药品：HKI-272
其他名称：
  • 来那替尼

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
Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel
大体时间：From first dose date through day 28
Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
From first dose date through day 28
Maximum Tolerated Dose
大体时间：From first dose date through day 28.
Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with paclitaxel 80 mg/m², intravenous at days 1, 8, and 15, associated with the dose limiting toxicity data.
From first dose date through day 28.
Objective Response Rate
大体时间：From first dose date to progression or last tumor assessment, up to 140 weeks
Subjects with partial response (PR) or complete response (CR) with ERBB2 positive breast cancer treated at the maximum tolerated dose (MTD) of neratinib in combination with paclitaxel, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and no progressive disease (PD) for non-target lesions, and no new lesions.
From first dose date to progression or last tumor assessment, up to 140 weeks

次要结果测量

结果测量
措施说明
大体时间
Maximum Plasma Concentration of Neratinib
大体时间：Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Maximum plasma concentration of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.
Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Area Under the Concentration-time Curve 0-24
大体时间：Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Area under the concentration-time curve of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.
Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.

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

Puma Biotechnology, Inc.

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

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)

2007年9月11日

初级完成 (实际的)

2011年5月1日

研究完成 (实际的)

2018年2月7日

研究注册日期

首次提交

2007年3月8日

首先提交符合 QC 标准的

2007年3月8日

首次发布 (估计)

2007年3月9日

研究记录更新

最后更新发布 (实际的)

2018年7月26日

上次提交的符合 QC 标准的更新

2018年6月27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

  • 3144A1-203 / B1891014

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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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罕见疾病

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