Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.

Tularik9 个研究点分布在 1 个国家目标入组 35 人开始时间: 2002年7月1日最近更新: 2005年6月24日

适应症

试验速览

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating non-Hodgkin's lymphoma.

•Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL)
•Subjects must have received prior chemotherapy for their NHL
•At least 18 years of age
•Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
•Karnofsky performance status of at least 70%
•Estimated life expectancy of at least 12 weeks
•Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
•Subject must be able to comply with study procedures and follow-up examinations.
•Signed written informed consent
•Lab Values (obtained ≤ 7 days prior to study enrollment):
•ANC at least 1.5x10e9/L,
•Platelet count at least 100x10e9/L,
•Hemoglobin at least 8.5 g/dL,
•Creatinine within 2 times upper limit of normal,
•AST and ALT within 3 times upper limit of normal,
•Bilirubin within 1.5 times upper limit of normal,
•Albumin great than 2.5 g/dL,

•Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
•NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms
•Patients who have received any investigational agent within 4 weeks of enrollment
•Patients who are pregnant or breast-feeding
•History of prior malignancy other than NHL within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
•History of central nervous system metastases or carcinomatous meningitis
•Major surgery within 4 weeks of enrollment

发起方

Tularik

申办方类型

Industry

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