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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tularik

Criteria

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