Back to resultsThe Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
Primary Purpose
Gastrointestinal Stromal Tumors, Soft Tissue Sarcomas
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD2171
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring cancer, tumour, advanced cancer, Metastatic Gastro-Intestinal Stromal Tumours, gastro-intestinal cancer, RECENTIN
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
-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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385203
Brief Title
The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors, Soft Tissue Sarcomas
Keywords
cancer, tumour, advanced cancer, Metastatic Gastro-Intestinal Stromal Tumours, gastro-intestinal cancer, RECENTIN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD2171
Other Intervention Name(s)
cediranib, RECENTIN™
Intervention Description
45 mg oral tablet once daily dose
Primary Outcome Measure Information:
Title
Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.
Description
[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.
Title
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.
Description
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.
Secondary Outcome Measure Information:
Title
Objective Tumour Response, Investigator Review
Description
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.
Title
-Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.
Description
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
Title
Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.
Description
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.
Time Frame
CT assessments at Baseline and Week 16.
Title
Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.
Description
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
Title
Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Robertson, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Sutton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24714778
Citation
Judson I, Scurr M, Gardner K, Barquin E, Marotti M, Collins B, Young H, Jurgensmeier JM, Leahy M. Phase II study of cediranib in patients with advanced gastrointestinal stromal tumors or soft-tissue sarcoma. Clin Cancer Res. 2014 Jul 1;20(13):3603-12. doi: 10.1158/1078-0432.CCR-13-1881. Epub 2014 Apr 8.
Results Reference
derived
Learn more about this trial
The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
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