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Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

NCT00777153 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2016-12-28

Study results available
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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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Jane Robertson · AstraZeneca

  • Tracy Batchelor, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-04-30
Completion
2016-09-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00777153 on ClinicalTrials.gov