Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00777153
• Date of registration: 20/10/2008
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma REGAL
• 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
• Date of first enrolment: October 2008
• Target sample size: 423
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00777153
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Jane Robertson
• Affiliation: AstraZeneca

• Name: Tracy Batchelor, MD, MPH
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Recurrent Glioblastoma

Intervention(s)

Drug: Cediranib

Drug: Placebo Cediranib

Drug: Lomustine Chemotherapy

Primary Outcome(s)

Progression Free Survival (PFS) [Time Frame: Baseline at 6 weeks and then every 6 weeks to discontinuation]

Secondary Outcome(s)

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]

Overall Survival (OS) [Time Frame: Baseline through to date of death up to 25th April 2010]

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]

Alive and Progression Free Rate at 6 Months (APF6) [Time Frame: 6 Months]

Response Rate [Time Frame: Baseline at 6 weeks and then every 6 weeks to discontinuation]

Secondary ID(s)

D8480C00055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/12/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00777153