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Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
This study is ongoing, but not recruiting participants.
Study NCT00043446   Information provided by Tularik
First Received: August 8, 2002   Last Updated: June 23, 2005   History of Changes

August 8, 2002
June 23, 2005
July 2002
 
 
 
Complete list of historical versions of study NCT00043446 on ClinicalTrials.gov Archive Site
 
 
 
Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
 

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

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Ovarian Neoplasms
Drug: intravenous T900607-sodium
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
35
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043446
 
T-607-005
Tularik
 
Study Chair: Kerrie Boyd Tularik
Tularik
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP