A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer

Aronex Pharmaceuticals0 个研究点目标入组 111 人开始时间: 2004年4月20日最近更新: 2005年6月24日

适应症

试验速览

阶段: 1 期
发起方: Aronex Pharmaceuticals
入组人数: 111

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase II, the primary objective is to evaluate survival after therapy with Aroplatin and gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

详细描述

Phase I Primary Objective:

Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.

Phase II Primary Objective:

Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.

Phase II Secondary Objective:

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

•Prior therapy for pancreatic cancer;
•Previously diagnosed brain metastases if symptomatic and requiring active therapy;
•Other cancers within the last five years, with the exception of adequately treated cone-biopsied in-situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
•Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study
•Primary or secondary immunodeficiency, or use of corticosteroids immunosuppressive medication;
•Women must not be pregnant or breast-feeding;
•Participation in any clinical trial involving investigational drugs within one month from enrollment into the present study.

研究者

发起方

Aronex Pharmaceuticals

申办方类型

Industry

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