Safety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme

Millennium Pharmaceuticals, Inc.30 enrolled

Overview

This is a safety study of tandutinib in combination with temozolomide and bevacizumab after people have received radiation therapy and temozolomide treatment. This study will determine the maximum safe dose of tandutinib when combined with temozolomide and bevacizumab and evaluate the safety of the combination treatment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme

Interventions

Tandutinib, bevacizumab, and temozolomideDRUG

All patients will have completed treatment with concurrent radiation therapy and temozolomide. Patients will be entered into different dosing groups of tandutinib. Patients will receive up to 6 cycles of treatment with oral temozolomide at 150 mg/m2 daily for the first 5 days of a 28 day cycle, oral tandutinib at escalating doses 250, 375, 500, or 625 mg twice daily on days 1 to 28, and intravenous bevacizumab at 10 mg/kg on days 1 and 15 of each cycle

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of glioblastoma multiforme * Received radiotherapy for glioblastoma multiforme * Patients who have not had previous treatments for glioblastoma multiforme (except for surgery, radiation and temozolomide therapy) * Females that are postmenopausal for at least 1 year prior to screening visit * 18 years of age and older Exclusion Criteria: * Other brain cancers that are not diagnosed as glioblastoma multiforme * female patients who are lactating or are pregnant * HIV positive and/or any other active infection requiring therapy * Known hepatitis B or hepatitis C infection * Diagnosed or treated any other cancer within 2 years before the first dose * History of cardiovascular conditions and/or vascular disease * Allergic to any component of bevacizumab

Outcomes

Primary Outcomes

Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements

Time frame: Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15

Data from ClinicalTrials.gov

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