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

Hoffmann-La Roche22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (4)

Unnamed facility

København Ø, Denmark

Unnamed facility

Marseille, France

Unnamed facility

Zurich, Switzerland

Unnamed facility

Manchester, United Kingdom

Outcomes