SB-743921 In Patients With Solid Tumors

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Solid Tumor Cancer

Treatments: Drug: SB-743921

Study type: Interventional

Funder types: Industry

Identifiers

NCT00136513

743921/001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)