To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue Sarcoma (STS) resistant to standard therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
45 mg oral tablet once daily dose
Research Site
Manchester, United Kingdom
Research Site
Sutton, United Kingdom
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.
Time frame: Baseline and 8 days after dosing.
Tumour Metabolic Activity as Assessed by Change in Central Review of Standardised Uptake Value (SUVMax) at Day 29, in Patients With GIST Tumours. SUVmax at Day 29 Minus SUVmax at Baseline.
SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients
Time frame: FDG-PET assessment at Baseline and 29 days after dosing.
Objective Tumour Response, Investigator Review
Number of patients with complete (CR) /partial response (PR) (based on RECIST) as assessed by the Investigator. CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.
Time frame: RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.
-Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.
Central review of CT images taking the longest diameter measured in millimetres at week 8 \[major axis (axial plane)\] minus the longest diameter measured in millimetres at baseline.
Time frame: CT assessments at Baseline and Week 8
Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.
Central review of CT images taking the longest diameter measured in millimetres at week 16 \[major axis (axial plane)\] minus the longest diameter measured in millimetres at baseline.
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Time frame: CT assessments at Baseline and Week 16.
Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.
Central review of CT images taking the total lesion volume at week 8 minus the total lesion volume at baseline.
Time frame: CT assessments at Baseline and Week 8
Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.
Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline.
Time frame: CT assessments at Baseline and Week 16