Clinical trial NCT00385203: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumors
Soft Tissue Sarcomas
Keywords: cancer
tumour
advanced cancer
Metastatic Gastro-Intestinal Stromal Tumours
gastro-intestinal cancer
RECENTIN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.
timeFrame: Baseline and 8 days after dosing.
measure: 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.
timeFrame: FDG-PET assessment at Baseline and 29 days after dosing.
Secondary outcomes:
measure: Objective Tumour Response, Investigator Review
timeFrame: RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.
measure: -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.
timeFrame: CT assessments at Baseline and Week 8
measure: Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.
timeFrame: CT assessments at Baseline and Week 16.
measure: Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.
timeFrame: CT assessments at Baseline and Week 8
measure: Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.
timeFrame: CT assessments at Baseline and Week 16
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson, MD
role: STUDY_DIRECTOR
References:
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.