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

Phase 1

Withdrawn

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Tandutinib, bevacizumab, and temozolomide

• Registration Number: NCT00904852
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-05
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Last Update Submitted: 2009-05-19
• Study First Posted: 2009-05-20
• Last Update Posted: 2009-05-20
• Study Start: 2009-06
• Primary Completion: 2010-05
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tandutinib, bevacizumab, and temozolomide	Tandutinib, bevacizumab, and temozolomide	tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.

Primary Outcome Measures

Name	Time	Method
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