Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma (REGAL)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
423 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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