A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma

• Status: Completed
• Trial end date: 2015-09-09
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Dacarbazine; Temozolomide

Criteria

Key Inclusion Criteria:

• newly diagnosed glioblastoma

• World Health Organization (WHO) performance status less than or equal to (<=2)

• stable or decreasing corticosteroid dose within 5 days prior to randomization

Key Exclusion Criteria:

• evidence of recent hemorrhage on postoperative magnetic resonance imaging (MRI) of brain

• any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas

• any prior radiotherapy to brain

• clinically significant cardiovascular disease

• history of greater than or equal to (>=) grade 2 hemoptysis within 1 month prior to randomization

• previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status for enrollment into a clinical trial