Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
1 other identifier
interventional
35
1 country
5
Brief Summary
The purpose of this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 8, 2002
CompletedFirst Posted
Study publicly available on registry
August 12, 2002
CompletedJune 24, 2005
April 1, 2004
August 8, 2002
June 23, 2005
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tulariklead
Study Sites (5)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kerrie Boyd
Tularik
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2002
First Posted
August 12, 2002
Study Start
July 1, 2002
Last Updated
June 24, 2005
Record last verified: 2004-04