Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.

Pfizer9 个研究点分布在 3 个国家目标入组 28 人开始时间: 2005年2月最近更新: 2008年10月27日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Pfizer
入组人数: 28
试验地点: 9
主要终点: assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
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 melanoma not responding to 1st line chemotherapy
•Histological evidence of melanoma
•Measurable disease according to RECIST criteria
•ECOG performance status less than or equal to 2
•Life expectancy 6 months or more
•Normal organ and bone marrow function as defined by hematological and serum chemistry limits
•Adequate contraception for females of childbearing potential

排除标准

•Stage IV disease which has previously progressed during interferon treatment.
•Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
•History of uncontrolled seizure disorders
•Uncontrolled coagulation disorders.
•History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
•History of uncontrolled intercurrent or chronic illness
•Concurrent malignancies.
•Brain metastases.
•HIV positive.
•Prolonged QTc interval
•Uncontrolled intercurrent or chronic illnesses.
•Pregnant or lactating women

结局指标

主要结局

assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks

次要结局

to assess the safety of the dosage regiment over 12 weeks
to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (9)

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