An Open-Label, Phase II Study to Evaluate the Biological Activity of Cediranib (AZD2171) as Measured by [F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET) Response, in Patients With Metastatic Gastro-Intestinal Stromal Tumours (GIST) Resistant or Intolerant to Imatinib Mesylate
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.
[F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET). Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours. SUVmax at Day 8 minus SUVmax at Baseline.
Baseline and 8 days after dosing.
Jane Robertson, MD
United Kingdom: Medicines and Healthcare Products Regulatory Agency