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

Tularik

Status and phase

Terminated

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: intravenous T900607-sodium

Study type

Interventional

Funder types

Industry

Identifiers

T-607-007

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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