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
Recruitment status was Active, not recruiting
Sponsor:
Tularik
Information provided by:
Tularik
ClinicalTrials.gov Identifier:
NCT00043446
First received: August 8, 2002
Last updated: June 23, 2005
Last verified: April 2004
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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:
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
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 May 19, 2013