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

Ovarian Neoplasms Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00043446
• Other study ID #: T-607-005
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 8, 2002
• Last updated: June 23, 2005
• Start date: July 2002

Study information

• Verified date: April 2004
• Source: Tularik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Drug:
• intravenous T900607-sodium

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Roswell Park Cancer Center	Buffalo	New York
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Tularik

Country where clinical trial is conducted

United States,