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
1 other identifier
interventional
423
9 countries
61
Brief Summary
The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2008
Longer than P75 for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 20, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedResults Posted
Study results publicly available
December 21, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedDecember 28, 2016
October 1, 2016
1.5 years
October 20, 2008
April 3, 2012
November 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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: 1. 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. 2. The patient has died from any cause. 3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.
Baseline at 6 weeks and then every 6 weeks to discontinuation
Secondary Outcomes (5)
Overall Survival (OS)
Baseline through to date of death up to 25th April 2010
Response Rate
Baseline at 6 weeks and then every 6 weeks to discontinuation
Alive and Progression Free Rate at 6 Months (APF6)
6 Months
Daily Steroid Dose
Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25
Steroid Free Days
Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25
Study Arms (3)
Cediranib 30mg
EXPERIMENTALCediranib 30mg
Cediranib 20mg + lomustine
OTHERCediranib 20mg + lomustine
Lomustine and Placebo Cediranib
ACTIVE COMPARATORLomustine and Placebo Cediranib
Interventions
110 mg/m2 / Q6W, oral, until progression
Eligibility Criteria
You may qualify if:
- Confirmation of recurrent glioblastoma
- Life expectancy ≥ 12 weeks
- Received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide
You may not qualify if:
- Patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to randomisation
- Poorly controlled hypertension
- Previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (62)
Research Site
Birmingham, Alabama, United States
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Pheonix, Arizona, United States
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Los Angeles, California, United States
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New Haven, Connecticut, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Kansas City, Kansas, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Amherst, New York, United States
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New York, New York, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Camperdown, Australia
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Heidelberg, Australia
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Nedlands, Australia
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Parkville, Australia
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St Leonards, Australia
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Woodville, Australia
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Graz, Austria
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Brussels (Anderlecht), Belgium
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Brussels (Jette), Belgium
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Brussels (Woluwé-St-Lambert), Belgium
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Leuven, Belgium
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Liberec, Czechia
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Bobigny, France
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Marseille, France
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Paris, France
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Rennes, France
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Saint-Herblain, France
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Villejuif, France
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Berlin, Germany
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Bielefeld, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Göttingen, Germany
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Hanover, Germany
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Heidelberg, Germany
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Kiel, Germany
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Leipzig, Germany
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Nordhausen, Germany
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Regensburg, Germany
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Amsterdam, Netherlands
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Groningen, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Glasgow, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Sutton, United Kingdom
Related Publications (1)
Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jurgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.
PMID: 23940216DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Jane Robertson
AstraZeneca
- PRINCIPAL INVESTIGATOR
Tracy Batchelor, MD, MPH
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2008
First Posted
October 22, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2010
Study Completion
September 1, 2016
Last Updated
December 28, 2016
Results First Posted
December 21, 2012
Record last verified: 2016-10