SB-743921 In Patients With Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Solid Tumor Cancer

Intervention / Treatment
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* Drug: SB-743921


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB-743921|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, dose limiting toxicity, solid tumors