Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)
- To compare progression-free survival, overall survival, radiological response, and
safety and tolerability of cediranib maleate in combination with gefitinib versus
cediranib maleate in combination with a placebo in patients with recurrent or
progressive glioblastoma following standard front-line treatment.
OUTLINE: This is a multicenter study.
Patients receive cediranib maleate and gefitinib or cediranib maleate and a placebo once
daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or
Blood and tissue samples are collected from some patients for genetic profiling and
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
from the date of randomisation to the date of first progression or death due to any cause
Paul Mulholland, PhD, MRCP, MSC, MBBS
University College London Hospitals
United Kingdom: Medicines and Healthcare Products Regulatory Agency