A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal; Bevacizumab

Criteria

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Histologically confirmed glioblastoma

• Radiographic demonstration of disease progression by Response Assessment in Neurooncology (RANO) criteria following prior therapy

• Availability of at least 1 formalin-fixed paraffin-embedded tumor tissue sample

• If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids

• Prior standard radiotherapy for glioblastoma

• Karnofsky Performance status >/=70

• Over 4 weeks since prior surgical resection

• Over 12 weeks from radiotherapy

• Over 4 weeks from anticancer agents

Exclusion Criteria:

• Patients had second or later glioblastoma relapse

• Patients received more than one systemic treatment regimen for glioblastoma

• Patients have secondary glioblastoma

• Prior treatment with Avastin

• Patients unable to undergo Magnetic Resonance Imaging (MRI)