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NCT00777153 · ClinicalTrials.gov registry record · Phase 3
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
A Phase 3 study of Recurrent Glioblastoma, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 423
- Enrollment target
- 20
- Study locations
NCT00777153: Completed Phase 3 study of Recurrent Glioblastoma, sponsored by AstraZeneca.
NCT00777153 is a Phase 3 study of Recurrent Glioblastoma that has completed, run by AstraZeneca. The registered enrollment target is 423 participants, above the 62-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (582% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00777153, a Phase 3 study of Recurrent Glioblastoma, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 423 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
For patients with measurable disease at entry (at least one lesion that has a shortest diameter ≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that: 1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being co
Conditions Studied
Interventions
- DRUG Cediranib
- DRUG Lomustine Chemotherapy
- DRUG Placebo Cediranib
Study Locations (20)
Ohio
- Research Site - Cincinnati
- Research Site - Cleveland
- Research Site - Columbus
Florida
- Research Site - Gainesville
- Research Site - Jacksonville
Illinois
- Research Site - Chicago
- Research Site - Evanston
New York
- Research Site - Amherst
- Research Site - New York
Pennsylvania
- Research Site - Philadelphia
- Research Site - Pittsburgh
Alabama
- Research Site - Birmingham
Arizona
- Research Site - Pheonix
California
- Research Site - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2008-10 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
What the finished NCT00777153 record still lists
NCT00777153 is an interventional study that assigns participants to a tested intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap, above the 62-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (582% higher).
The record links to 1 condition, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Cediranib is the first listed.
NCT00777153 names 20 study sites across 14 states, led by Ohio, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00777153 about?
NCT00777153 is a clinical study titled "Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma". 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 ...
What is the current status of trial NCT00777153?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 423 participants. The study started on 2008-10. Estimated completion is 2016-09.
What conditions does trial NCT00777153 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma.
What interventions are being tested in trial NCT00777153?
The interventions under investigation include: Cediranib (DRUG), Lomustine Chemotherapy (DRUG), Placebo Cediranib (DRUG).
Who is sponsoring clinical trial NCT00777153?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00777153 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00777153's enrollment target sits among peer trials
423 3rd of 62 higher than 60 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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