NCT00904852

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

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.

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Tandutinib, bevacizumab, and temozolomide	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

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2009-05-20
• Last updated: 2009-05-20