Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.

Tularik10 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 this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer.

•Histologically or cytologically confirmed diagnosis of ovarian cancer
•Subjects must have received 1-2 regimens of prior chemotherapy (with one containing paclitaxel)
•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
•INR < 1.5 for subjects without anticoagulants

•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 ovarian cancer 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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