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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by Tularik.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tularik
ClinicalTrials.gov Identifier:
NCT00043446
First received: August 8, 2002
Last updated: June 23, 2005
Last verified: April 2004
  Purpose

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


Condition Intervention Phase
Ovarian Neoplasms
Drug: intravenous T900607-sodium
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Tularik:

Estimated Enrollment: 35
Study Start Date: July 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043446

Locations
United States, California
Scripps Health Center
La Jolla, California, United States, 92037
USC Women's and Children's Hospital
Los Angeles, California, United States, 90033
University of California San Francisco
San Francisco, California, United States, 94115
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Tularik
Investigators
Study Chair: Kerrie Boyd Tularik
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00043446     History of Changes
Other Study ID Numbers: T-607-005
Study First Received: August 8, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 26, 2014