The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastrointestinal Stromal Tumors, Soft Tissue Sarcomas

Intervention / Treatment
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* Drug: AZD2171


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological confirmation of GIST which is resistant or intolerant to imatinib mesylate, or metastatic STS, which is refractory to standard therapies or for which no standard therapy exists Exclusion Criteria: Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes. Patients with a history of poorly controlled high blood pressure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD2171|45 mg oral tablet once daily dose|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | FDG-PET assessment at Baseline and 29 days after dosing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | CT assessments at Baseline and Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, tumour, advanced cancer, Metastatic Gastro-Intestinal Stromal Tumours, gastro-intestinal cancer, RECENTIN