Overview

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