Ovarian Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT00043446

Recruitment Status:

Unknown status

Sponsor:

Tularik

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There are 5 Locations for this study

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Scripps Health Center
La Jolla California, 92037, United States
USC Women's and Children's Hospital
Los Angeles California, 90033, United States
University of California San Francisco
San Francisco California, 94115, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Roswell Park Cancer Center
Buffalo New York, 14263, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT00043446

Recruitment Status:

Unknown status

Sponsor:


Tularik

How clear is this clinincal trial information?

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