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ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

2009年4月28日更新者：ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.

研究概览

地位

完全的

条件

干预/治疗

药品：ARQ 501 in combination with gemcitabine

详细说明

This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. The study objectives are:

Primary Objective:

Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine.

Secondary Objectives:

Determine time to tumor progression (TTP) of patients treated with ARQ 501 in combination with gemcitabine
Further characterize the safety of ARQ 501 in combination with gemcitabine

研究类型

介入性

注册

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
  - Mobile、Alabama、美国、36693
    - University of South Alabama
- California
  - La Jolla、California、美国、92093
    - Moores UCSD Cancer Center
  - Rancho Mirage、California、美国、92270
    - Desert Hematology Oncology Medical Group, Inc.
  - San Diego、California、美国、92161
    - VA San Diego Healthcare System
  - San Diego、California、美国、92121
    - Scripps Cancer Center
- Illinois
  - Chicago、Illinois、美国、60637
    - University Of Chicago Medical Center
- Kentucky
  - Lexington、Kentucky、美国、40536
    - University of Kentucky Medical Center
  - Lexington、Kentucky、美国、40536
    - Unversity of Kentucky Medical Center - Markey Center
- Maryland
  - Baltimore、Maryland、美国、21231
    - The Sidney Kimmel Comprehensive Cancer Center
- Massachusetts
  - Boston、Massachusetts、美国、02114
    - Massachusetts General Hospital
  - Boston、Massachusetts、美国、02115
    - Jeffrey Meyerhardt
- New York
  - Bronx、New York、美国、10461
    - Jacobi Medical Center
- Pennsylvania
  - Pittsburgh、Pennsylvania、美国、15232
    - University of Pittsburgh Medical Center
- Texas
  - Houston、Texas、美国、77030
    - Baylor College of Medicine
- Virginia
  - Richmond、Virginia、美国、23230
    - Virginia Cancer Institute

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:

Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma
Be treatment-naïve.
Have measurable disease per RECIST Criteria.
Be ≥18 years old.
Have a Karnofsky Performance Status (KPS) of ≥70%.
Have an estimated life expectancy of ≥12 weeks.
Be male or a non-pregnant, non-lactating female patient. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.
Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
Sign a written informed consent form.
Have adequate organ function as indicated by acceptable laboratory values obtained within 7 days prior to the first dose of study drug.

Exclusion Criteria:

Have received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
Are pregnant or lactating.
Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Have symptomatic or untreated central nervous system (CNS) metastases.
Have a known hypersensitivity to gemcitabine.

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：单组作业
屏蔽：无（打开标签）

研究衡量的是什么？

主要结果指标

结果测量
Document progression free survival after treatment with ARQ 501 and gemcitabine

次要结果测量

结果测量
Document safety and efficacy of ARQ 501 in combination with gemcitabine

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

ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

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

2005年1月1日

初级完成 (实际的)

2007年1月1日

研究完成 (实际的)

2007年1月1日

研究注册日期

首次提交

2005年2月1日

首先提交符合 QC 标准的