Phase 3
Completed N=325
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
Source: ClinicalTrials.gov NCT00777153 ↗Enrolled (actual)
325
Serious AEs
40.0%
Results posted
Dec 2012
Primary outcomePrimary: Progression Free Survival (PFS) — 92; 125; 82 Days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
92; 125; 82 | — |
| SECONDARY Overall Survival (OS) |
8.0; 9.4; 9.8 | — |
| SECONDARY Response Rate |
18; 21; 5 | — |
| SECONDARY Alive and Progression Free Rate at 6 Months (APF6) |
16.2; 34.5; 24.5 | — |
| SECONDARY Daily Steroid Dose |
-17.6; -1.8; 36.6 | — |
| SECONDARY Steroid Free Days |
75.8; 74.8; 92.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00777153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.