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Phase 3
18 Years
Open (Enrolling)

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Trial Information

Inclusion Criteria:

- adult patients, >=18 years of age;

- newly diagnosed glioblastoma;

- World Health Organization (WHO) performance status <=2;

- stable or decreasing corticosteroid dose within 5 days prior to randomization.

Exclusion Criteria:

- evidence of recent hemorrhage or postoperative magnetic resonance imaging (MRI) of

- any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas;

- any prior radiotherapy to brain;

- clinically significant cardiovascular disease;

- history of >=grade 2 hemoptysis within 1 month prior to randomization;

- previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status
for enrollment into a clinical trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator

Outcome Description:

PFS was defined as the time from randomization to disease progression or death due to any cause. Disease progression (PD) was assessed by the investigator using adapted Macdonald response criteria (modified World Health Organization (WHO) criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging (MRI) scans, neurological assessment and changes in corticosteroid use. PD was determined as ≥ 25% increase in the sum of the products of the perpendicular longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir) during the study or unequivocal progression of existing non-index lesions (non-enhancing and enhancing, non-measurable) or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) with no need for a confirmatory scan. Data from the final analysis is presented.

Outcome Time Frame:

Randomization until Progressive Free Survival Event [Until data cutoff= 31 March 2012 (up to 34 months)]

Safety Issue:


Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

October 2013

Related Keywords:

  • Glioblastoma
  • Glioblastoma



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