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Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC

2016年7月28日 更新者：Boehringer Ingelheim

A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer

The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.

The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.

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)

143

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

  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大
        • 1230.5.00104 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Kelowna、British Columbia、加拿大
        • 1230.5.00114 Boehringer Ingelheim Investigational Site
      • Surrey、British Columbia、加拿大
        • 1230.5.00109 Boehringer Ingelheim Investigational Site
      • Vancouver、British Columbia、加拿大
        • 1230.5.00107 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton、Ontario、加拿大
        • 1230.5.00105 Boehringer Ingelheim Investigational Site
      • Kitchener、Ontario、加拿大
        • 1230.5.00119 Boehringer Ingelheim Investigational Site
      • Oshawa、Ontario、加拿大
        • 1230.5.00116 Boehringer Ingelheim Investigational Site
      • Ottawa、Ontario、加拿大
        • 1230.5.00108 Boehringer Ingelheim Investigational Site
      • Toronto、Ontario、加拿大
        • 1230.5.00110 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal、Quebec、加拿大
        • 1230.5.00102 Boehringer Ingelheim Investigational Site
      • Montreal、Quebec、加拿大
        • 1230.5.00106 Boehringer Ingelheim Investigational Site
  • 巴哈马
      • Nassau、巴哈马
        • 1230.5.00118 Boehringer Ingelheim Investigational Site

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:

  1. Pathologic or cytologic confirmed diagnosis of NSCLC
  2. Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
  3. Patients who are eligible for pemetrexed as second line chemotherapy
  4. Measurable disease by one or more techniques (CT, MRI) according to RECIST
  5. Patients aged 18 years or older
  6. Life expectancy of at least three (3) months
  7. Eastern Cooperative Oncology Group (ECOG) performance Score 0-2
  8. Written informed consent that is consistent with ICH-GCP guidelines and local legislation

Exclusion criteria:

  1. Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
  2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of Cycle 1 of this trial
  3. Any persisting toxicities which are deemed to be clinically significant from the previous therapy
  4. Patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
  5. Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
  6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded.
  7. Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
  8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
  9. Patients unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily
  10. Patients who have received prior therapy with pemetrexed
  11. Absolute neutrophil count (ANC) less than 1,500/mm3
  12. Platelet count less than 100,000/mm3
  13. Hemoglobin <90g/L
  14. Total bilirubin >26µmol/L
  15. Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
  16. Serum creatinine level >133µmol/L and/or creatinine clearance (measured or calculated) <45 ml/min
  17. Clinically relevant QTc prolongation
  18. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  19. Pregnancy or breast feeding
  20. Known or suspected active alcohol or drug abuse
  21. Patients unable to comply with the protocol
  22. Any known hypersensitivity to the trial drugs or their excipients
  23. Patients with NSCLC of confirmed Squamous histology

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：BI 6727 +pemetrexed
BI 6727 plus 500 mg/^m2 pemetrexed i.v. on day 1 of 21 day cycle
药品：pemetrexed
500 mg/m^2 i.v. on day 1 of 21 day cycle
药品：BI 6727
BI 6727 i.v. on day 1 of a 21 day cycle
有源比较器：pemetrexed
500 mg/m^2 i.v. on day 1 of a 21 day cycle
药品：pemetrexed
500 mg/m^2 i.v. on day 1 of 21 day cycle

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
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.
大体时间：From randomization until disease progression or death

Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.

The number of participants analysed displays the number of patients with an event (progression).
From randomization until disease progression or death

次要结果测量

结果测量
措施说明
大体时间
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
大体时间：From first drug infusion until 21 days after last drug infusion, up to 1100 days
Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Overall Survival (OS)
大体时间：From randomization until time of death
Overall survival (OS) was defined as the duration of time from randomization to time of death.
From randomization until time of death
Duration of Overall Response
大体时间：From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.
From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
Occurrence and Intensity of AEs Graded According to CTCAE.
大体时间：From first drug infusion until 21 days after last drug infusion, up to 1100 days
All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE).
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Occurence of DLT
大体时间：Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.

Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:

  • treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).
  • treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.
  • CTCAE Grade 4 thrombocytopenia.
Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.
Frequency of Patients With Possible Clinically Significant Abnormalities
大体时间：From first drug infusion until 21 days after last drug infusion, up to 1100 days
Frequency of patients with possible clinically significant abnormalities
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Cmax of Volasertib
大体时间：5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax - maximum measured concentration of volasertib in plasma.
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Total Clearance (CL) of Volasertib
大体时间：5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
CL - total clearance of volasertib in plasma after IV administration
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss of Volasertib
大体时间：5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss - apparent volume of distribution at steady state following IV administration of volasertib
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax of Pemetrexed
大体时间：5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Cmax - maximum measured concentration of pemetrexed in plasma
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL of Pemetrexed
大体时间：5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL - total clearance of pemetrexed in plasma after IV administration
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss of Pemetrexed
大体时间：5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion

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

Boehringer Ingelheim

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

有用的网址

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3月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2009年1月15日

首先提交符合 QC 标准的

2009年1月15日

首次发布 (估计)

2009年1月16日

研究记录更新

最后更新发布 (估计)

2016年9月20日

上次提交的符合 QC 标准的更新

2016年7月28日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1230.5

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