Overview

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)