SB-743921 In Patients With Solid Tumors

GlaxoSmithKline30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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 Outcomes

Tumor response Comparison of pre and post-dose biomarker levels and/or correlation of pre-dose biomarker levels to any subsequent tumor response.