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

Status unconfirmed · Phase 2

Conditions studied: Ovarian Neoplasms

In brief

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

Key facts

Study ID

NCT00043446

Run by

Tularik

People needed

35

Starts

2002-07-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Health Center — La Jolla, California, United States
• USC Women's and Children's Hospital — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Roswell Park Cancer Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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