Phase 2
N=36
The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
Gastrointestinal Stromal Tumors · Soft Tissue Sarcomas
Bottom Line
View on ClinicalTrials.gov: NCT00385203 ↗Enrolled (actual)
36
Serious AEs
38.2%
Results posted
Jul 2012
Primary outcome: Primary: Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients. — -0.515 g/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD2171 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients. |
-0.515 | — |
| 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. |
-0.172 | — |
| SECONDARY Objective Tumour Response, Investigator Review |
0; 4 | — |
| SECONDARY -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images. |
2.734; -1.015 | — |
| SECONDARY Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images. |
5.028; -8.114 | — |
| SECONDARY Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images. |
19889.31; 5106.30 | — |
| SECONDARY Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images. |
43202.54; -6479.65 | — |
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
Data sourced from ClinicalTrials.gov (NCT00385203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.