- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00043446
Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
June 23, 2005 updated by: Tularik
The purpose of this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Scripps Health Center
-
Los Angeles, California, United States, 90033
- USC Women's and Children's Hospital
-
San Francisco, California, United States, 94115
- University of California San Francisco
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kerrie Boyd, Tularik
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Study Registration Dates
First Submitted
August 8, 2002
First Submitted That Met QC Criteria
August 9, 2002
First Posted (Estimate)
August 12, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T-607-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Neoplasms
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Ovarian Carcinoma | Ovarian Neoplasm | Ovarian Clear Cell Tumor | Adnexal Mass | Ovarian Endometrioid Tumor | Ovarian Serous Tumor | Borderline Ovarian Epithelial TumorUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Maastricht University Medical CenterVieCuri Medical Centre; Orbis Medical Centre; St.Jans Gasthuis Weert; Laurentius...TerminatedOvarian Cancer | Ovarian Carcinoma | Ovarian Cyst | Ovarian MassNetherlands
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Medical University of LublinCompletedOvarian Cancer | Unexplained Infertility | Borderline Ovarian Tumors | Benign Ovarian TumorPoland
-
Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
Clinical Trials on intravenous T900607-sodium
-
TularikUnknownHepatocellular CarcinomaUnited States, China
-
TularikTerminatedNon-Hodgkin's LymphomaUnited States
-
TularikSuspendedGastric Cancer | Esophageal NeoplasmsUnited States
-
University Hospitals Seidman Cancer CenterNational Cancer Institute (NCI)Completed
-
University Hospitals Seidman Cancer CenterNational Cancer Institute (NCI)Completed
-
Sheba Medical CenterTel Aviv UniversityCompletedVerifying the Correct Position of Intravenous CathetersIsrael
-
The Western Pennsylvania HospitalWest Penn Allegheny Health SystemWithdrawnContrast Induced NephropathyUnited States
-
Guy's and St Thomas' NHS Foundation TrustActive, not recruiting
-
Imperial College LondonCompleted
-
Hospital Universitario Ramon y CajalCompletedHeart Failure | Diabetes | Kidney Failure, Chronic | Kidney Failure, AcuteSpain