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

Phase 2

Completed

• Conditions: Gastrointestinal Stromal Tumors; Soft Tissue Sarcomas

• Registration Number: NCT00385203
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-05
• Study First Submitted QC: 2006-10-05
• Study First Posted: 2006-10-06
• Primary Completion: 2008-06
• Study Completion: 2009-12
• Disposition First Submitted: 2011-04-06
• Disposition First Submitted QC: 2011-04-06
• Disposition First Posted: 2011-04-12
• Results First Submitted: 2012-03-28
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-11
• Last Update Submitted: 2012-06-11
• Results First Posted: 2012-07-16
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.	Baseline and 8 days after dosing.	\[F 18\] 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.	FDG-PET assessment at Baseline and 29 days after dosing.	SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients

Secondary Outcome Measures

Name	Time	Method
Objective Tumour Response, Investigator Review	RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.	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.	CT assessments at Baseline and Week 8	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.	CT assessments at Baseline and Week 16.	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.	CT assessments at Baseline and Week 8	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.	CT assessments at Baseline and Week 16	Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, United Kingdom