CClinicalTrials.gg
TerminatedNCT00043459Updated Jun 24, 2005

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

A Phase 2 interventional study of intravenous T900607-sodium in Non-Hodgkin's Lymphoma, sponsored by Tularik. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Tularik · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Non-Hodgkin's Lymphoma

Keywords

  • NHL
03

In context

Lymphoma

5,577 studies on the registry are indexed under Lymphoma; 824 are open to participants now.

This study's enrollment of 35 is below the median of 40 across 4,507 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Tularik is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants

Interventions

  • Drugintravenous T900607-sodium
06

Study locations

5 sites
  • Scripps Health Center
    La Jolla, California 92037, United States
  • University of Colorado Health Sciences Center
    Aurora, Colorado 80010, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Rush Medical Center
    Chicago, Illinois 60612, United States
  • Weill Medical College of Cornell University
    New York, New York 10021, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00043459
Lead sponsor
Tularik
First posted
Aug 12, 2002
Start date
Jul 2002
Completion
Mar 2003
Last update
Jun 24, 2005

Study contacts

Kerrie Boyd
study chair · Tularik
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2003. You cannot join it, but the record below documents what was studied.

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