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SB-743921 In Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00136513
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : October 16, 2008
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to find a dose of SB-743921 in adult patients with solid tumors or lymphoma who have progressed on standard therapy or who have relapsed. SB-743921 is dosed by 1-hour intravenous infusion every 3 weeks. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of the drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with SB-743921. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

Condition or disease Intervention/treatment Phase
Solid Tumor Cancer Drug: SB-743921 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Administration of SB743921 on a Once Every 3 Week Schedule in Patients With Solid Tumors
Study Start Date : April 2004
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability will include evaluation of adverse events (AE) and changes from baseline in vital signs and clinical laboratory parameters. PK endpoints will include Cl, Vd, AUC, Cmax, and t½.

Secondary Outcome Measures :
  1. Tumor response Comparison of pre and post-dose biomarker levels and/or correlation of pre-dose biomarker levels to any subsequent tumor response.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Histologically or cytologically confirmed diagnosis of: a) Advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy; OR b) B-cell or T-cell lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate) AND/OR for which salvage chemotherapy, radiotherapy, or bone marrow transplantation is not indicated or has been refused by the patient.
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.

Exclusion criteria:

  • Pre-existing hemolytic anemia.
  • Pre-existing peripheral neuropathy greater than or equal grade 2.
  • Absolute neutrophil count less than 1,500/mm3.
  • Platelets less than 100,000/mm3.
  • Hemoglobin less than 9 g/dL.
  • Total bilirubin greater than1.5 mg/dL.
  • AST/ALT greater than 2.5 X upper limit of normal.
  • Creatinine clearance less than or equal to 60 mL/min.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136513

United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00136513     History of Changes
Other Study ID Numbers: 743921/001
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
dose limiting toxicity
solid tumors