- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00777153
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma (REGAL)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Camperdown, Australia
- Research Site
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Heidelberg, Australia
- Research Site
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Nedlands, Australia
- Research Site
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Parkville, Australia
- Research Site
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St Leonards, Australia
- Research Site
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Woodville, Australia
- Research Site
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Graz, Austria
- Research Site
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Brussels (Anderlecht), Belgium
- Research Site
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Brussels (Jette), Belgium
- Research Site
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Brussels (Woluwé-St-Lambert), Belgium
- Research Site
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Leuven, Belgium
- Research Site
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Alberta
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Calgary, Alberta, Canada
- Research Site
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Ontario
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Toronto, Ontario, Canada
- Research Site
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Quebec
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Montreal, Quebec, Canada
- Research Site
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Liberec, Czech Republic
- Research Site
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Bobigny, France
- Research Site
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Marseille, France
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Paris cedex 13, France
- Research Site
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Rennes, France
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Saint Herblain, France
- Research Site
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Villejuif, France
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Berlin, Germany
- Research Site
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Bielefeld, Germany
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Dresden, Germany
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Düsseldorf, Germany
- Research Site
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Göttingen, Germany
- Research Site
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Hannover, Germany
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Heidelberg, Germany
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Kiel, Germany
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Leipzig, Germany
- Research Site
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Nordhausen, Germany
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Regensburg, Germany
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Amsterdam, Netherlands
- Research Site
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Den Haag, Netherlands
- Research Site
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Groningen, Netherlands
- Research Site
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Maastricht, Netherlands
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Rotterdam, Netherlands
- Research Site
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Glasgow, United Kingdom
- Research Site
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London, United Kingdom
- Research Site
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Manchester, United Kingdom
- Research Site
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Sutton, United Kingdom
- Research Site
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Alabama
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Birmingham, Alabama, United States
- Research Site
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Arizona
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Pheonix, Arizona, United States
- Research Site
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California
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Los Angeles, California, United States
- Research Site
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Connecticut
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New Haven, Connecticut, United States
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Florida
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Gainesville, Florida, United States
- Research Site
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Jacksonville, Florida, United States
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Illinois
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Chicago, Illinois, United States
- Research Site
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Evanston, Illinois, United States
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Kansas
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Kansas City, Kansas, United States
- Research Site
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Detroit, Michigan, United States
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New York
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Amherst, New York, United States
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New York, New York, United States
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Ohio
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Cincinnati, Ohio, United States
- Research Site
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Research Site
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Pittsburgh, Pennsylvania, United States
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Texas
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Houston, Texas, United States
- Research Site
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Washington
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Seattle, Washington, United States
- Research Site
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West Virginia
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Morgantown, West Virginia, United States
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Cediranib 30mg
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30 mg/day, oral, until progression
20 mg/day, oral, until progression
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OTHER: Cediranib 20mg + lomustine
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30 mg/day, oral, until progression
20 mg/day, oral, until progression
110 mg/m2 / Q6W, oral, until progression
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ACTIVE_COMPARATOR: Lomustine and Placebo Cediranib
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110 mg/m2 / Q6W, oral, until progression
Oral, until progression
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression Free Survival (PFS)
Time Frame: Baseline at 6 weeks and then every 6 weeks to discontinuation
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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:
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Baseline at 6 weeks and then every 6 weeks to discontinuation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Survival (OS)
Time Frame: Baseline through to date of death up to 25th April 2010
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Number of months from randomisation to the date of death from any cause
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Baseline through to date of death up to 25th April 2010
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Response Rate
Time Frame: Baseline at 6 weeks and then every 6 weeks to discontinuation
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An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present. An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan. |
Baseline at 6 weeks and then every 6 weeks to discontinuation
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Alive and Progression Free Rate at 6 Months (APF6)
Time Frame: 6 Months
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Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques.
Values are percentages.
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6 Months
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Daily Steroid Dose
Time Frame: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25
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The mean steroid dosage prior to treatment will be considered as the patient's baseline.
The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md - bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.
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Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25
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Steroid Free Days
Time Frame: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25
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Number of days known not to have used any steroids prior to progression
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Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tracy Batchelor, MD, MPH, Massachusetts General Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Protein Kinase Inhibitors
- Lomustine
- Cediranib
Other Study ID Numbers
- D8480C00055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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