Trial · NCT00385203
The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
NCT00385203, Phase 2, Completed, AstraZeneca; results first posted 2012-07-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST). Trials, record NCT00385203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00385203
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
- NCT number
- NCT00385203
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Gastrointestinal Stromal Tumors, Soft Tissue Sarcomas
- Interventions
- AZD2171
- First posted
- 2006-10-06
- Last updated
- 2012-07-16
- Results first posted
- 2012-07-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients. | 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. |
| 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. | FDG-PET assessment at Baseline and 29 days after dosing. | SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients |
| Secondary | Objective Tumour Response, Investigator Review | 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. |
| Secondary | -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images. | 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. |
| Secondary | Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images. | 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. |
| Secondary | Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images. | 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. |
| Secondary | Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images. | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients. | Baseline and 8 days after dosing. | As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 8). | g/mL | MEAN |
| 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. | FDG-PET assessment at Baseline and 29 days after dosing. | As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 29). | g/mL | MEAN |
| SECONDARY | Objective Tumour Response, Investigator Review | RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression. | Participants | NUMBER | |
| SECONDARY | -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images. | CT assessments at Baseline and Week 8 | As per the protocol the formal statistical analysis was performed for the GIST grouppatients only, STS patients were summarised (not STS patients). For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8). | mm | MEAN |
| SECONDARY | Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images. | CT assessments at Baseline and Week 16. | As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8). | mm | MEAN |
| SECONDARY | Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images. | CT assessments at Baseline and Week 8 | As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8). | cm3 | MEAN |
| SECONDARY | Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images. | CT assessments at Baseline and Week 16 | As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8). | cm3 | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients. | Cediranib 45 mg/Day GIST | -0.515 | 95% Confidence Interval -1.480 to 0.450 | g/mL | |
| 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. | Cediranib 45 mg/Day GIST | -0.172 | 95% Confidence Interval -1.380 to 1.040 | g/mL | |
| Objective Tumour Response, Investigator Review | Cediranib 45 mg/Day GIST | 0 | Participants | ||
| Objective Tumour Response, Investigator Review | Cediranib 45 mg/Day STS | 4 | Participants | ||
| -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images. | Cediranib 45 mg/Day GIST | 2.734 | 95% Confidence Interval -1.76 to 7.230 | mm | |
| -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images. | Cediranib 45 mg/Day STS | -1.015 | 95% Confidence Interval -7.22 to 5.19 | mm | |
| Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images. | Cediranib 45 mg/Day GIST | 5.028 | 95% Confidence Interval -1.120 to 11.180 | mm | |
| Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images. | Cediranib 45 mg/Day STS | -8.114 | 95% Confidence Interval -15.74 to -0.49 | mm | |
| Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images. | Cediranib 45 mg/Day GIST | 19889.31 | 95% Confidence Interval -7054.96 to 46833.58 | cm3 | |
| Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images. | Cediranib 45 mg/Day STS | 5106.30 | 95% Confidence Interval -21840.10 to 32052.70 | cm3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cediranib 45 mg/Day GIST | 26 | |
| Overall Study | STARTED | Cediranib 45 mg/Day STS | 10 | |
| Overall Study | COMPLETED | Cediranib 45 mg/Day GIST | 0 | |
| Overall Study | COMPLETED | Cediranib 45 mg/Day STS | 3 | |
| Overall Study | NOT COMPLETED | Cediranib 45 mg/Day GIST | 26 | |
| Overall Study | NOT COMPLETED | Cediranib 45 mg/Day STS | 7 |
Source ClinicalTrials.gov
Adverse events206
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cediranib 45 mg/Day GIST | 2 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Cediranib 45 mg/Day STS | 0 | 10 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cediranib 45 mg/Day GIST | 0 | 24 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cediranib 45 mg/Day STS | 1 | 10 | |
| other | Palpitations | Cardiac disorders | Cediranib 45 mg/Day GIST | 0 | 24 | |
| other | Palpitations | Cardiac disorders | Cediranib 45 mg/Day STS | 3 | 10 | |
| other | Tachycardia | Cardiac disorders | Cediranib 45 mg/Day GIST | 1 | 24 | |
| other | Tachycardia | Cardiac disorders | Cediranib 45 mg/Day STS | 2 | 10 | |
| other | Splinter Haemorrhages | Cardiac disorders | Cediranib 45 mg/Day GIST | 0 | 24 | |
| other | Splinter Haemorrhages | Cardiac disorders | Cediranib 45 mg/Day STS | 1 | 10 |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cediranib 45 mg/Day GIST | ||
| Total, all-cause mortality | Cediranib 45 mg/Day STS | ||
| Total, other adverse events | Cediranib 45 mg/Day GIST | 24 | 24 |
| Total, other adverse events | Cediranib 45 mg/Day STS | 10 | 10 |
| Total, serious adverse events | Cediranib 45 mg/Day GIST | 10 | 24 |
| Total, serious adverse events | Cediranib 45 mg/Day STS | 3 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24714778 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cediranib 45 mg/Day GIST vs Cediranib 45 mg/Day STS: Objective Tumour Response, Investigator Review | Trial comparisons |
| Cediranib 45 mg/Day GIST vs Cediranib 45 mg/Day STS: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00385203
GET https://conductscience.org/api/trials/v1/NCT00385203/events?page=2