此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Combination With Gemcitabine in Advanced Pancreatic Cancer (BAGPAC)

2021年4月6日 更新者：Bayer

A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer

Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.

Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.

Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.

Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.

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)

90

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

  • 德国
      • Berlin、德国、13353
    • Baden-Württemberg
      • Heilbronn、Baden-Württemberg、德国、74078
    • Bayern
      • München、Bayern、德国、81377
    • Hessen
      • Marburg、Hessen、德国、35033
    • Nordrhein-Westfalen
      • Bochum、Nordrhein-Westfalen、德国、44892
  • 意大利
    • Lombardia
      • Brescia、Lombardia、意大利、25124
    • Marche
      • Ancona、Marche、意大利、60126
  • 挪威
      • Oslo、挪威
      • Oslo、挪威、0310
  • 捷克语
      • Brno、捷克语、602 00
      • Olomouc、捷克语、775 20
  • 比利时
      • Bruxelles - Brussel、比利时、1070
      • Bruxelles - Brussel、比利时、1090
      • Edegem、比利时、2650
  • 法国
      • CLERMONT-FERRAND Cedex 1、法国、63003
  • 波兰
      • Bialystok、波兰、15-027
      • Gdansk、波兰、80-952
      • Warszawa、波兰、02-781
  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
    • Massachusetts
      • Pittsfield、Massachusetts、美国、01201
  • 英国
      • London、英国
      • London、英国、SE1 9RT
      • London、英国、WC1E 6BT

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 至 99年 (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:

  • Male or female patients ≥18 years of age
  • Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery
  • Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1
  • Resolution of all acute toxic effects of any prior local treatment to Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1
  • Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2
  • Patient has cardiac function, within normal range, as measured by an echocardiogram

Exclusion Criteria:

  • Known history of, or symptomatic metastatic brain or meningeal tumors
  • History of cardiac disease
  • Active clinically serious infections
  • Clinically significant (ie. symptomatic) peripheral vascular disease
  • Pregnant or lactating women; women of childbearing potential not employing adequate contraception
  • Use of strong inhibitors or inducers of CYP3A4
  • Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy
  • Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment
  • Thrombotic or embolic events such within 6 months prior to start of study treatment

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：不适用
  • 介入模型：单组作业
  • 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：手臂 1
药品：BAY86-9766+Gemcitabine
Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
大体时间：From randomization up to the first 8 weeks of therapy
From randomization up to the first 8 weeks of therapy
Tumor Response (Adjudicated Blinded Read Assessment): Phase II
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks

次要结果测量

结果测量
大体时间
Tumor Response: Investigator Assessment: Phase I
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase I
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase II
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response (DOR): Phase I
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response: Phase II
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase I
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase II
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase I
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase II
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase I
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase II
大体时间：From start of treatment until 134 weeks assessed every 8 weeks
From start of treatment until 134 weeks assessed every 8 weeks

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

Bayer

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。

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 (实际的)

2011年1月1日

初级完成 (实际的)

2013年2月11日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2010年11月8日

首先提交符合 QC 标准的

2010年12月1日

首次发布 (估计)

2010年12月2日

研究记录更新

最后更新发布 (实际的)

2021年4月8日

上次提交的符合 QC 标准的更新

2021年4月6日

最后验证

2021年4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

  • 14905
  • 2010-019588-12 (EudraCT编号)

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.

订阅