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

Gastrointestinal Stromal Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385203
• Other study ID #: D8480C00046
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2006
• Last updated: June 11, 2012
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• Sarcoma
• Soft Tissue Sarcomas

Intervention

Drug:
• AZD2171
45 mg oral tablet once daily dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	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.	No
Secondary	-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	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No

External Links

•   Astrazeneca Information - outside of the US