Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Recurrent Glioblastoma

In brief

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.

Key facts

Study ID

NCT00777153

Run by

AstraZeneca

People needed

423

Starts

2008-10-01

Expected to finish

2016-09-01

Last updated by the study team

2016-12-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmation of recurrent glioblastoma
• Life expectancy ≥ 12 weeks
• Received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide

You may not qualify if…

• Patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to randomisation
• Poorly controlled hypertension
• Previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy

Where it is running

• Research Site — Pheonix, Arizona, United States
• Research Site — Los Angeles, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Amherst, New York, United States
• Research Site — New York, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Houston, Texas, United States
• Research Site — Seattle, Washington, United States
• Research Site — Morgantown, West Virginia, United States
• Research Site — Camperdown, Australia
• Research Site — Heidelberg, Australia
• Research Site — Nedlands, Australia
• Research Site — Parkville, Australia
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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