A Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN)

Sponsor
Genentech, Inc.
Study ID
NCT00345163
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a Phase II, open-label, multicenter, randomized, non comparative study consisting of two concurrent single-arms. Approximately 160 subjects will be randomized in a 1:1 ratio to Arm 1 (bevacizumab alone) or Arm 2 (bevacizumab + irinotecan).

Key Dates

Start date
Jul 31, 2006
Status verified
May 2017
Primary completion
Sep 30, 2007
Completion
Sep 30, 2007

Study Design

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

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

Objective response, as determined by the independent review facility (IRF) [ Time Frame: Complete response or partial response, determined on two consecutive assessments ≥4 weeks apart ]

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