Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 7/8/2016 |
| Start Date: | October 2008 |
| End Date: | January 2017 |
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
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.
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.
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
We found this trial at
22
sites
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