Overview

This trial is active, not recruiting.

Condition recurrent glioblastoma
Treatments cediranib, lomustine chemotherapy, placebo cediranib
Phase phase 3
Target VEGF
Sponsor AstraZeneca
Start date October 2008
End date April 2010
Trial size 423 participants
Trial identifier NCT00777153, D8480C00055

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Cediranib 30mg
cediranib
30 mg/day, oral, until progression
(Other)
Cediranib 20mg + lomustine
cediranib
20 mg/day, oral, until progression
lomustine chemotherapy
110 mg/m2 / Q6W, oral, until progression
(Active Comparator)
Lomustine and Placebo Cediranib
lomustine chemotherapy
110 mg/m2 / Q6W, oral, until progression
placebo cediranib
Oral, until progression

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Baseline at 6 weeks and then every 6 weeks to discontinuation

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Baseline through to date of death up to 25th April 2010
Response Rate
time frame: Baseline at 6 weeks and then every 6 weeks to discontinuation
Alive and Progression Free Rate at 6 Months (APF6)
time frame: 6 Months
Daily Steroid Dose
time frame: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25
Steroid Free Days
time frame: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title 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
Principal investigator Tracy Batchelor, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.