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

June 11, 2012 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: AZD2171

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Manchester, United Kingdom
    - Research Site
  - Sutton, United Kingdom
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

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. Time Frame: 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.	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. Time Frame: FDG-PET assessment at Baseline and 29 days after dosing.	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 Time Frame: 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.	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. Time Frame: 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.	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. Time Frame: 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.	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. Time Frame: 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.	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. Time Frame: 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.	CT assessments at Baseline and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Jane Robertson, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 5, 2006

First Submitted That Met QC Criteria