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

Sponsor
Hoffmann-La Roche
Study ID
NCT01308684
Phase
PHASE1
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO5323441 + bevacizumab [Avastin] — DRUG
    Dose-Finding part: RO5323441 intravenous escalating doses once every two weeks; Efficacy-Finding part: established dose from the Dose-Finding part; Avastin: 10 mg/kg intravenously once every two weeks
  • bevacizumab [Avastin] — DRUG
    Efficacy-Finding part: 10 mg/kg intravenously once every two weeks

Study Details

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.

Key Dates

First listed
Mar 4, 2011
Start date
May 31, 2011
Status verified
Nov 2016
Primary completion
Feb 28, 2013
Completion
Feb 28, 2013

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

Dose-Finding Part: Dose limiting toxicity [ Time Frame: Day 28 ]

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