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Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma (REGAL)

Primary Purpose

Recurrent Glioblastoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cediranib
Cediranib
Lomustine Chemotherapy
Placebo Cediranib
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring Cancer, Tumour, Advanced Solid Tumour, GBM, Glioblastoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Active Comparator

Arm Label

Cediranib 30mg

Cediranib 20mg + lomustine

Lomustine and Placebo Cediranib

Arm Description

Cediranib 30mg

Cediranib 20mg + lomustine

Lomustine and Placebo Cediranib

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
Number of months from randomisation to the date of death from any cause
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.
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.
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.
Steroid Free Days
Number of days known not to have used any steroids prior to progression

Full Information

First Posted
October 20, 2008
Last Updated
November 7, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00777153
Brief Title
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
Acronym
REGAL
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
Keywords
Cancer, Tumour, Advanced Solid Tumour, GBM, Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
423 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cediranib 30mg
Arm Type
Experimental
Arm Description
Cediranib 30mg
Arm Title
Cediranib 20mg + lomustine
Arm Type
Other
Arm Description
Cediranib 20mg + lomustine
Arm Title
Lomustine and Placebo Cediranib
Arm Type
Active Comparator
Arm Description
Lomustine and Placebo Cediranib
Intervention Type
Drug
Intervention Name(s)
Cediranib
Intervention Description
30 mg/day, oral, until progression
Intervention Type
Drug
Intervention Name(s)
Cediranib
Intervention Description
20 mg/day, oral, until progression
Intervention Type
Drug
Intervention Name(s)
Lomustine Chemotherapy
Intervention Description
110 mg/m2 / Q6W, oral, until progression
Intervention Type
Drug
Intervention Name(s)
Placebo Cediranib
Intervention Description
Oral, until progression
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
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.
Time Frame
Baseline at 6 weeks and then every 6 weeks to discontinuation
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Number of months from randomisation to the date of death from any cause
Time Frame
Baseline through to date of death up to 25th April 2010
Title
Response Rate
Description
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.
Time Frame
Baseline at 6 weeks and then every 6 weeks to discontinuation
Title
Alive and Progression Free Rate at 6 Months (APF6)
Description
Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.
Time Frame
6 Months
Title
Daily Steroid Dose
Description
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.
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
Title
Steroid Free Days
Description
Number of days known not to have used any steroids prior to progression
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Robertson
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tracy Batchelor, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Pheonix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
Country
United States
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Research Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
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Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
Country
United States
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Research Site
City
Boston
State/Province
Massachusetts
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United States
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City
Detroit
State/Province
Michigan
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United States
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Amherst
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New York
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United States
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City
New York
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New York
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United States
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Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
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Research Site
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Cleveland
State/Province
Ohio
Country
United States
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Research Site
City
Columbus
State/Province
Ohio
Country
United States
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Philadelphia
State/Province
Pennsylvania
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United States
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Pittsburgh
State/Province
Pennsylvania
Country
United States
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Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
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Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Research Site
City
Camperdown
Country
Australia
Facility Name
Research Site
City
Heidelberg
Country
Australia
Facility Name
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City
Nedlands
Country
Australia
Facility Name
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Parkville
Country
Australia
Facility Name
Research Site
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St Leonards
Country
Australia
Facility Name
Research Site
City
Woodville
Country
Australia
Facility Name
Research Site
City
Graz
Country
Austria
Facility Name
Research Site
City
Brussels (Anderlecht)
Country
Belgium
Facility Name
Research Site
City
Brussels (Jette)
Country
Belgium
Facility Name
Research Site
City
Brussels (Woluwé-St-Lambert)
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
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City
Liberec
Country
Czech Republic
Facility Name
Research Site
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Bobigny
Country
France
Facility Name
Research Site
City
Marseille
Country
France
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Paris cedex 13
Country
France
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Research Site
City
Rennes
Country
France
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Research Site
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Saint Herblain
Country
France
Facility Name
Research Site
City
Villejuif
Country
France
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Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bielefeld
Country
Germany
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Research Site
City
Dresden
Country
Germany
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Research Site
City
Düsseldorf
Country
Germany
Facility Name
Research Site
City
Göttingen
Country
Germany
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City
Hannover
Country
Germany
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Research Site
City
Heidelberg
Country
Germany
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City
Kiel
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
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Research Site
City
Nordhausen
Country
Germany
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Research Site
City
Regensburg
Country
Germany
Facility Name
Research Site
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Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Den Haag
Country
Netherlands
Facility Name
Research Site
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Groningen
Country
Netherlands
Facility Name
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Maastricht
Country
Netherlands
Facility Name
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Rotterdam
Country
Netherlands
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Glasgow
Country
United Kingdom
Facility Name
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London
Country
United Kingdom
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Manchester
Country
United Kingdom
Facility Name
Research Site
City
Sutton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23940216
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=425&filename=CSR-D8480C00055.pdf
Description
Related Info

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Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

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