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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00385203
First received: October 5, 2006
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Soft Tissue Sarcomas
Drug: AZD2171
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    [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. [ Time Frame: FDG-PET assessment at Baseline and 29 days after dosing. ] [ Designated as safety issue: No ]
    SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients


Secondary Outcome Measures:
  • Objective Tumour Response, Investigator Review [ Time Frame: RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression. ] [ Designated as safety issue: No ]
    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. [ Time Frame: CT assessments at Baseline and Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: CT assessments at Baseline and Week 16. ] [ Designated as safety issue: No ]
    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. [ Time Frame: CT assessments at Baseline and Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: CT assessments at Baseline and Week 16 ] [ Designated as safety issue: No ]
    Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline.


Enrollment: 35
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD2171
    45 mg oral tablet once daily dose
    Other Names:
    • cediranib
    • RECENTIN™
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385203

Locations
United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Sutton, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00385203     History of Changes
Other Study ID Numbers: D8480C00046
Study First Received: October 5, 2006
Results First Received: March 28, 2012
Last Updated: June 11, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
cancer
tumour
advanced cancer
Metastatic Gastro-Intestinal Stromal Tumours
gastro-intestinal cancer
RECENTIN

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Sarcoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 14, 2014