Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

For patients with measurable disease at entry (at least one lesion that has a shortest diameter ≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that: The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days. The patient has died from any cause. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.

Outcome Time Frame:

Baseline at 6 weeks and then every 6 weeks to discontinuation

Safety Issue:

No

Principal Investigator

Jane Robertson

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D8480C00055

NCT ID:

NCT00777153

Start Date:

October 2008

Completion Date:

June 2013

Related Keywords:

• Recurrent Glioblastoma
• Cancer
• Tumour
• Advanced Solid Tumour
• GBM
• Glioblastoma
• Glioblastoma