Overview

Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Cediranib
Lomustine
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