NCT00777153

Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Cediranib	30 mg/day, oral, until progression
DRUG	Cediranib	20 mg/day, oral, until progression
DRUG	Lomustine Chemotherapy	110 mg/m2 / Q6W, oral, until progression
DRUG	Placebo Cediranib	Oral, until progression

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-04-01
• Completion: 2016-09-01
• First posted: 2008-10-22
• Last updated: 2016-12-28
• Results posted: 2012-12-21

Locations

62 sites across 10 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Netherlands, United Kingdom