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Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour

Study Purpose

This is a Phase I, open-label, multi-centre study designed to assess the safety and tolerability of Cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.

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:

- Primary recurrent malignant brain tumour for whom lomustine would be standard therapy - diagnosis & stage.

- Patients received no more than 2 previous systemic chemotherapy regimes.

- Life Expectancy > 12 weeks.

- Patients must be at least 3 months from the completion of cranial radiation therapy.

Exclusion Criteria:

- History of poorly controlled high blood pressure.

- Recent major surgery prior to entry into the study

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.	NCT00503204
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 1
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
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	United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma, Brain Tumor

Arms & Interventions

Arms

Experimental: 1

Lomustine + Cediranib (AZD2171)

Interventions

Drug: - Cediranib

oral tablet

Drug: - Lomustine

oral capsule

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, Boston, Massachusetts

Status

Address

Research Site

Boston, Massachusetts,

International Sites

Research Site, Sutton, United Kingdom