This trial is active, not recruiting.

Condition ovarian neoplasms
Treatment intravenous t900607-sodium
Phase phase 2
Sponsor Tularik
Start date July 2002
Trial size 35 participants
Trial identifier NCT00043446, T-607-005


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Tularik.