Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
NCT ID: NCT00043446
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2002-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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intravenous T900607-sodium
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Tularik
INDUSTRY
Principal Investigators
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Kerrie Boyd
Role: STUDY_CHAIR
Tularik
Locations
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Scripps Health Center
La Jolla, California, United States
USC Women's and Children's Hospital
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Countries
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Other Identifiers
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T-607-005
Identifier Type: -
Identifier Source: org_study_id