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

Glioblastoma Multiforme Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00904852
• Other study ID #: C03003
• Status: Withdrawn
• Phase: Phase 1
• First received: May 19, 2009
• Last updated: May 19, 2009
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2009
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes