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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00777153




Registration number
NCT00777153
Ethics application status
Date submitted
20/10/2008
Date registered
22/10/2008
Date last updated
28/12/2016

Titles & IDs
Public title
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
Scientific title
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
Secondary ID [1] 0 0
D8480C00055
Universal Trial Number (UTN)
Trial acronym
REGAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Glioblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cediranib
Treatment: Drugs - Cediranib
Treatment: Drugs - Lomustine Chemotherapy
Treatment: Drugs - Placebo Cediranib

Experimental: Cediranib 30mg - Cediranib 30mg

Other: Cediranib 20mg + lomustine - Cediranib 20mg + lomustine

Active Comparator: Lomustine and Placebo Cediranib - Lomustine and Placebo Cediranib


Treatment: Drugs: Cediranib
30 mg/day, oral, until progression

Treatment: Drugs: Cediranib
20 mg/day, oral, until progression

Treatment: Drugs: Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression

Treatment: Drugs: Placebo Cediranib
Oral, until progression

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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:
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.
Timepoint [1] 0 0
Baseline at 6 weeks and then every 6 weeks to discontinuation
Secondary outcome [1] 0 0
Overall Survival (OS) - Number of months from randomisation to the date of death from any cause
Timepoint [1] 0 0
Baseline through to date of death up to 25th April 2010
Secondary outcome [2] 0 0
Response Rate - 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.
Timepoint [2] 0 0
Baseline at 6 weeks and then every 6 weeks to discontinuation
Secondary outcome [3] 0 0
Alive and Progression Free Rate at 6 Months (APF6) - Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.
Timepoint [3] 0 0
6 Months
Secondary outcome [4] 0 0
Daily Steroid Dose - 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.
Timepoint [4] 0 0
Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25
Secondary outcome [5] 0 0
Steroid Free Days - Number of days known not to have used any steroids prior to progression
Timepoint [5] 0 0
Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25

Eligibility
Key inclusion criteria
- Confirmation of recurrent glioblastoma

- Life expectancy = 12 weeks

- Received only one prior systemic chemotherapy regimen and this regimen must contain
temozolomide
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment hospital [3] 0 0
Research Site - Nedlands
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment hospital [5] 0 0
Research Site - St Leonards
Recruitment hospital [6] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- St Leonards
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
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Michigan
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United States of America
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New York
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United States of America
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Ohio
Country [12] 0 0
United States of America
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Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
United States of America
State/province [15] 0 0
West Virginia
Country [16] 0 0
Austria
State/province [16] 0 0
Graz
Country [17] 0 0
Belgium
State/province [17] 0 0
Brussels (Anderlecht)
Country [18] 0 0
Belgium
State/province [18] 0 0
Brussels (Jette)
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussels (Woluwé-St-Lambert)
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Liberec
Country [25] 0 0
France
State/province [25] 0 0
Bobigny
Country [26] 0 0
France
State/province [26] 0 0
Marseille
Country [27] 0 0
France
State/province [27] 0 0
Paris cedex 13
Country [28] 0 0
France
State/province [28] 0 0
Rennes
Country [29] 0 0
France
State/province [29] 0 0
Saint Herblain
Country [30] 0 0
France
State/province [30] 0 0
Villejuif
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Bielefeld
Country [33] 0 0
Germany
State/province [33] 0 0
Dresden
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Germany
State/province [34] 0 0
Düsseldorf
Country [35] 0 0
Germany
State/province [35] 0 0
Göttingen
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Germany
State/province [36] 0 0
Hannover
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Germany
State/province [37] 0 0
Heidelberg
Country [38] 0 0
Germany
State/province [38] 0 0
Kiel
Country [39] 0 0
Germany
State/province [39] 0 0
Leipzig
Country [40] 0 0
Germany
State/province [40] 0 0
Nordhausen
Country [41] 0 0
Germany
State/province [41] 0 0
Regensburg
Country [42] 0 0
Netherlands
State/province [42] 0 0
Amsterdam
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Netherlands
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Den Haag
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Netherlands
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Groningen
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Netherlands
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Maastricht
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Netherlands
State/province [46] 0 0
Rotterdam
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Glasgow
Country [48] 0 0
United Kingdom
State/province [48] 0 0
London
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Manchester
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00777153
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jane Robertson
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications