Ovarian Neoplasms
Conditions
Brief summary
The purpose of this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer.
Interventions
Sponsors
Tularik
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Countries
United States
Outcome results
None listed