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A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

2019年3月11日 更新者：AmpliMed Corporation

A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)

The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

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)

142

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

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35205
        • Birmingham Hematology and Oncology- US Oncology
    • Arizona
      • Tucson、Arizona、美国、85715
        • Arizona Clinical Research Center
      • Tucson、Arizona、美国、85704
        • AZ Onc Associates D.B.A. Hematology Oncology- US Oncology
    • Colorado
      • Denver、Colorado、美国、80218
        • Rocky Mountain Cancer Center- US Oncology
    • Florida
      • Ocala、Florida、美国、34471
        • Ocala Oncology Center- US Oncology
      • Orlando、Florida、美国、34761
        • Cancer Centers of Florida- US Oncology
    • Georgia
      • Atlanta、Georgia、美国、30309
        • Peachtree Hematology and Oncology Consultants
    • Illinois
      • Chicago、Illinois、美国、60611
        • Hematology Oncology Associates of Illinois- US Oncology
      • Niles、Illinois、美国、60714
        • Cancer Care & Hematolog Specialists of Chicagoland- US Oncology
    • Indiana
      • Indianapolis、Indiana、美国、46227
        • Central Indiana Cancer Centers- US Oncology
      • South Bend、Indiana、美国、46601
        • Northern Indiana Cancer Research Consortium
      • Terre Haute、Indiana、美国、47802
        • Hope Center- US Oncology
    • Kentucky
      • Lexington、Kentucky、美国、40536-0093
        • University of Kentucky, Hematology/Oncology/BMT Clinical Research
    • Massachusetts
      • Burlington、Massachusetts、美国、01805
        • Lahey Clinic
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota
    • Missouri
      • Kansas City、Missouri、美国、64131
        • Kansas City Cancer Center, LLC- US Oncology
    • Nevada
      • Las Vegas、Nevada、美国、89169
        • Comprehensive Cancer Centers of Nevada- US Oncology
    • New Jersey
      • Flemington、New Jersey、美国、08822
        • Hunterdon Regional Cancer Center
      • Mount Holly、New Jersey、美国、08060
        • Hematology Oncology Associates
    • New Mexico
      • Albuquerque、New Mexico、美国、87131
        • University of New Mexico
      • Albuquerque、New Mexico、美国、87106
        • Hematology Oncology Associates
      • Las Cruces、New Mexico、美国、88011
        • University of New Mexico Cancer Center South
      • Santa Fe、New Mexico、美国、87505
        • New Mexico Cancer Care Associates- US Oncology
    • New York
      • Buffalo、New York、美国、14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Raleigh、North Carolina、美国、27607
        • Cancer Center of North Carolina- US Oncology
    • Pennsylvania
      • Kingston、Pennsylvania、美国、18704
        • Medical Onc Assoc of Wyoming Valley, PC- US Oncology
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center
      • Pittsburgh、Pennsylvania、美国、15232
        • University of Pittsburgh Cancer Institute
      • Pottstown、Pennsylvania、美国、19464
        • Pottstown Memorial Medical Center
      • Upland、Pennsylvania、美国、19013
        • Associates in Hematology-Oncology P.C. US Oncology
      • West Reading、Pennsylvania、美国、19611
        • Reading Hospital Regional Medical Center
    • South Dakota
      • Sioux Falls、South Dakota、美国、57104
        • Sanford Clinic
    • Texas
      • Amarillo、Texas、美国、79106
        • Texas Oncology - Amarillo- US Oncology
      • Beaumont、Texas、美国、77702
        • Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology
      • Bedford、Texas、美国、76022
        • Texas Oncology P.A.- Bedford- US Oncology
      • Dallas、Texas、美国、75230
        • Texas Cancer Center at Medical City- US Oncology
      • Dallas、Texas、美国、75231
        • Texas Oncology P.A. - Dallas- US Oncology
      • Dallas、Texas、美国、75237
        • Methodist Charlton Cancer Center - Texas Oncology- US Oncology
      • Odessa、Texas、美国、79761
        • Texas Oncology - Odessa- US Oncology
      • Temple、Texas、美国、76508
        • Scott and White Hospital and Clinics
      • Waco、Texas、美国、76712
        • Texas Oncology Cancer Care and Research Center- US Oncology
      • Wichita Falls、Texas、美国、76310
        • Texoma Cancer Center- US Oncology
    • Virginia
      • Norfolk、Virginia、美国、23502
        • Virginia Oncology Associates- US Oncology
      • Salem、Virginia、美国、24153
        • Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology
    • Washington
      • Seattle、Washington、美国、98104
        • Swedish Cancer Institute
      • Spokane、Washington、美国、99202
        • Cancer Care Northwest- US Oncology
      • Vancouver、Washington、美国、98684
        • Northwest Cancer Specialists- US Oncology

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. Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
  2. At least one unidimensional measurable metastatic lesion by contrast enhanced CT scan (or MRI in patients ineligible for contrast enhanced CT) that are outside any prior radiation port.
  3. Age at least 18 years.
  4. ECOG performance status 0 or 1.
  5. No prior chemotherapy or radiation therapy.
  6. Projected life expectancy at least 2 months.
  7. If female, neither pregnant nor lactating.
  8. If of child bearing potential must agree to, and be able to use adequate contraception.
  9. Concomitant disease: No respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life threatening ventricular arrhythmias. No uncompensated CHF or NY Heart Association class 3 or 4 cardiac disease.
  10. No other concurrent active malignancy.
  11. No infection requiring parenteral antibiotic therapy at the start of protocol treatment.

  12. Laboratory values within the following criteria:

    Hgb greater than or equal to 9 gm/dL WBC greater than or equal 3,500/mm^3 ANC greater than or equal 1,500/mm^3 Platelet count greater than or equal 100,000/mm^3 Creatinine greater than or equal 2.0 Bilirubin less than or equal to 2.0 Hepatic enzymes (AST, ALT) less than or equal 3 times upper limit of normal (ULN)

  13. G6PD level greater than or equal lower limit of normal (LLN).
  14. Able to render informed consent and follow protocol requirements.

Exclusion Criteria:

  1. Patients with locally advanced, non-metastatic pancreas cancer (Stage III or below).
  2. Age less than 18 years.
  3. ECOG performance status 2 or greater.
  4. Prior anticancer drug therapy for metastatic disease.
  5. Ascites.
  6. Prior abdominal or thoracic surgery < 4 weeks before the start of therapy.
  7. Current or prior brain metastases. Brain MRI or CT required pre-registration only if the patient has CNS symptoms indicating a need for evaluation.
  8. Life expectancy projected less than 2 months.
  9. Pregnancy or lactation.
  10. Unable or unwilling to utilize medically acceptable contraception if of childbearing potential.
  11. Laboratory parameters outside of specified ranges, (see above).
  12. Infection requiring parenteral antibiotics.
  13. NY Heart Association stage 3 or 4 heart disease.
  14. Unable to render informed consent.
  15. Failure to meet any of the eligibility criteria as outlined above.

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：imexon + gemcitabine
药品：imexon in combination with gemcitabine
875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV
其他名称：
  • Amplimexon, Gemzar
有源比较器：Placebo + gemcitabine
Placebo in combination with gemcitabine
药品：imexon placebo + gemcitabine
imexon placebo IV + 1000 mg/m^2 gemcitabine IV
其他名称：
  • 金扎

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 for the Intent to Treat Population
大体时间：up to 2 years
To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
up to 2 years
To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events
大体时间：Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months
Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events
Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months

次要结果测量

结果测量
措施说明
大体时间
Objective Response Rates of the Two Treatment Arms
大体时间：one year
Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.
one year
Progression Free Survival
大体时间：one year
To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
one year

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

AmpliMed Corporation

调查人员

  • 研究主任：Evan Hersh, MD、AmpliMed Corporation

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)

2008年4月1日

初级完成 (实际的)

2010年5月1日

研究完成 (实际的)

2010年6月1日

研究注册日期

首次提交

2008年3月10日

首先提交符合 QC 标准的

2008年3月10日

首次发布 (估计)

2008年3月17日

研究记录更新

最后更新发布 (实际的)

2019年3月20日

上次提交的符合 QC 标准的更新

2019年3月11日

最后验证

2019年3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

  • AMP-019

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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