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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Multicenter, Open-Label, Dose Escalation Study of Tandutinib (Formerly MLN518) in Combination With Temozolomide and Bevacizumab Following Concurrent Radiation Therapy and Temozolomide in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme.

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Drug: Tandutinib, bevacizumab, and temozolomide


Participation Criteria
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Eligibility Criteria
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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

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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Accepts Healthy Volunteers

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tandutinib, bevacizumab, and temozolomide<br>tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment. | Drug: Tandutinib, bevacizumab, and temozolomide<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements |  | Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15 |