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

SB-743921 In Patients With Solid Tumors

Sponsors

Lead sponsor: GlaxoSmithKline

Source GlaxoSmithKline
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.

Overall Status Completed
Start Date April 2004
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Tumor response Comparison of pre and post-dose biomarker levels and/or correlation of pre-dose biomarker levels to any subsequent tumor response.
Enrollment 30
Condition
Intervention

Intervention type: Drug

Intervention name: SB-743921

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Location
facility
GSK Investigational Site | Pittsburgh, Pennsylvania, 15232, United States
GSK Investigational Site | Madison, Wisconsin, 53792, United States
Location Countries

United States

Verification Date

October 2008

Responsible Party

Name title: Study Director

Organization: GSK

Keywords
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov