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

Millennium Pharmaceuticals

Status and phase: Withdrawn; Phase 1

Conditions: Glioblastoma Multiforme

Treatments: Drug: Tandutinib, bevacizumab, and temozolomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904852

C03003

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Tandutinib, bevacizumab, and temozolomide

Experimental group

Description:

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

Treatment:

Drug: Tandutinib, bevacizumab, and temozolomide