Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma (REGAL)
|Recurrent Glioblastoma||Drug: Cediranib Drug: Lomustine Chemotherapy Drug: Placebo Cediranib||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|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|
- Progression Free Survival (PFS) [ Time Frame: Baseline at 6 weeks and then every 6 weeks to discontinuation ]
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.
- Overall Survival (OS) [ Time Frame: Baseline through to date of death up to 25th April 2010 ]Number of months from randomisation to the date of death from any cause
- Response Rate [ Time Frame: Baseline at 6 weeks and then every 6 weeks to discontinuation ]
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) [ Time Frame: 6 Months ]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 [ 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 ]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 [ 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 ]Number of days known not to have used any steroids prior to progression
|Study Start Date:||October 2008|
|Study Completion Date:||September 2016|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Cediranib 30mg
30 mg/day, oral, until progression
Cediranib 20mg + lomustine
Cediranib 20mg + lomustine
20 mg/day, oral, until progressionDrug: Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression
Active Comparator: Lomustine and Placebo Cediranib
Lomustine and Placebo Cediranib
Drug: Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progressionDrug: Placebo Cediranib
Oral, until progression
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777153
Show 62 Study Locations
|Study Director:||Jane Robertson||AstraZeneca|
|Principal Investigator:||Tracy Batchelor, MD, MPH||Massachusetts General Hospital|