A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies

Novacea2 个研究点分布在 1 个国家目标入组 45 人开始时间: 2004年8月1日最近更新: 2006年11月2日

适应症

试验速览

阶段: 1 期
发起方: Novacea
入组人数: 45
试验地点: 2

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The purposes of this study are to determine:

the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle
the side effects of AQ4N when given on the above schedule
how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N
if AQ4N helps treat cancer

详细描述

This study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably, effective treatments.

AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply; tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment. AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide, causing tumors to die or to delay their growth.

All patients in this study will receive AQ4N. The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
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

•Advanced solid malignancy or non-Hodgkin's lymphoma that is refractory to treatment or has recurred
•Age > 18 years
•Adequate hematologic (blood), kidney and liver function
•Negative pregnancy test (females of childbearing potential only)
•Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment.

排除标准

•Any chemotherapy or radiation within the past 4 weeks
•Symptomatic or uncontrolled brain metastases (patients with history of brain metastases who have had repeat brain scans within the past 30 days that demonstrate no evidence of tumor progression or brain swelling and who do not require corticosteriod treatment may be eligible)
•Significant cardiovascular illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, heart attack within the past six months, or uncontrolled, irregular heart beat
•Inadequate cardiac function
•Prior investigational therapy within the past 28 days
•Pregnant or breast feeding women

研究者

发起方

Novacea

申办方类型

Industry

研究点 (2)

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