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Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00777153
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jane RobertsonTracy Batchelor, MD, MPH
Principal Investigator Affiliation AstraZenecaMassachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Netherlands, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Cediranib 30mg

Cediranib 30mg

Other: Cediranib 20mg + lomustine

Cediranib 20mg + lomustine

Active Comparator: Lomustine and Placebo Cediranib

Lomustine and Placebo Cediranib

Interventions

Drug: - Cediranib

30 mg/day, oral, until progression

Drug: - Cediranib

20 mg/day, oral, until progression

Drug: - Lomustine Chemotherapy

110 mg/m2 / Q6W, oral, until progression

Drug: - Placebo Cediranib

Oral, until progression

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Birmingham, Alabama

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