Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.

Non-Hodgkin's Lymphoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00043459
• Other study ID #: T-607-007
• Status: Terminated
• Phase: Phase 2
• First received: August 8, 2002
• Last updated: June 23, 2005
• Start date: July 2002
• Est. completion date: March 2003

Study information

• Verified date: March 2003
• Source: Tularik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating non-Hodgkin's lymphoma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL)

• Subjects must have received prior chemotherapy for their NHL

• 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,

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 NHL 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 Design

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

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• intravenous T900607-sodium

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	Northwestern University	Chicago	Illinois
United States	Rush Medical Center	Chicago	Illinois
United States	Scripps Health Center	La Jolla	California
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tularik

Country where clinical trial is conducted

United States,