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A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Recurrent Glioblastoma

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Trial Information

A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone


Inclusion Criteria:



- Confirmation of recurrent glioblastoma

- Life expectancy ≥ 12 weeks

- Received only one prior systemic chemotherapy regimen and this regimen must contain
temozolomide

Exclusion Criteria:

- Patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to
randomisation

- Poorly controlled hypertension

- Previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy

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

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteHays, Kansas  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteHooksett, New Hampshire  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteAbilene, Texas  
Research SiteAuburn, Washington  
Research SiteClarksburg, West Virginia