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

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT00904852
Phase
PHASE1
Status
Withdrawn

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tandutinib, bevacizumab, and temozolomide — DRUG
    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

Study Details

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.

Key Dates

First listed
May 20, 2009
Start date
Jun 30, 2009
Status verified
May 2009
Primary completion
May 31, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tandutinib, bevacizumab, and temozolomide
    tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.

Primary Outcome Measure

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 ]

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