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

Primary Purpose

Ovarian Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
intravenous T900607-sodium
Sponsored by
Tularik
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Health Center
  • USC Women's and Children's Hospital
  • University of California San Francisco
  • Massachusetts General Hospital
  • Roswell Park Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 8, 2002
Last Updated
June 23, 2005
Sponsor
Tularik
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1. Study Identification

Unique Protocol Identification Number
NCT00043446
Brief Title
Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tularik

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intravenous T900607-sodium

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerrie Boyd
Organizational Affiliation
Tularik
Official's Role
Study Chair
Facility Information:
Facility Name
Scripps Health Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
USC Women's and Children's Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

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

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