Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

Recurrent Glioblastoma Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00777153
• Other study ID #: D8480C00055
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 20, 2008
• Last updated: July 6, 2016
• Start date: October 2008
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Agency for Health and Food SafetyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Ministry of Food, Agriculture and Consumer ProtectionNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 423
• Est. completion date: January 2017
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

Intervention

Drug:
• Cediranib
30 mg/day, oral, until progression
• Cediranib
20 mg/day, oral, until progression
• Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression
• Placebo Cediranib
Oral, until progression

Locations

Country	Name	City	State
Australia	Research Site	Camperdown
Australia	Research Site	Heidelberg
Australia	Research Site	Nedlands
Australia	Research Site	Parkville
Australia	Research Site	St Leonards
Australia	Research Site	Woodville
Austria	Research Site	Graz
Belgium	Research Site	Brussels (Anderlecht)
Belgium	Research Site	Brussels (Jette)
Belgium	Research Site	Brussels (Woluwé-St-Lambert)
Belgium	Research Site	Leuven
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Toronto	Ontario
Czech Republic	Research Site	Liberec
France	Research Site	Bobigny
France	Research Site	Marseille
France	Research Site	Paris cedex 13
France	Research Site	Rennes
France	Research Site	Saint Herblain
France	Research Site	Villejuif
Germany	Research Site	Berlin
Germany	Research Site	Bielefeld
Germany	Research Site	Dresden
Germany	Research Site	Düsseldorf
Germany	Research Site	Göttingen
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	Kiel
Germany	Research Site	Leipzig
Germany	Research Site	Nordhausen
Germany	Research Site	Regensburg
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Groningen
Netherlands	Research Site	Maastricht
Netherlands	Research Site	Rotterdam
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Sutton
United States	Research Site	Amherst	New York
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Detroit	Michigan
United States	Research Site	Evanston	Illinois
United States	Research Site	Gainesville	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kansas City	Kansas
United States	Research Site	Los Angeles	California
United States	Research Site	Morgantown	West Virginia
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Pheonix	Arizona
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline at 6 weeks and then every 6 weeks to discontinuation	No
Secondary	Overall Survival (OS)	Number of months from randomisation to the date of death from any cause	Baseline through to date of death up to 25th April 2010	No
Secondary	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.	Baseline at 6 weeks and then every 6 weeks to discontinuation	No
Secondary	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.	6 Months	No
Secondary	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.	Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25	No
Secondary	Steroid Free Days	Number of days known not to have used any steroids prior to progression	Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25	No

External Links

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