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

NCT ID: NCT00904852

Last Updated: 2009-05-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-06-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tandutinib, bevacizumab, and temozolomide

tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.

Group Type: EXPERIMENTAL

Tandutinib, bevacizumab, and temozolomide

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Millennium Pharmaceuticals, Inc.

Principal Investigators

Sudha Parasuraman, MD

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Other Identifiers

C03003

Identifier Type: -

Identifier Source: org_study_id