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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2171 | Drug | 45 mg oral tablet once daily dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients. | [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. | SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients | FDG-PET assessment at Baseline and 29 days after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumour Response, Investigator Review | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Manchester | United Kingdom | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24714778 | Derived | 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. |
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Enrolled: 45mg GIST=26, 45mg STS=10; Full analysis set: 45mg GIST=25, 45mg STS=10; Safety set: 45mg GIST=24, 45mg STS=10. 36 patients were enrolled and 35 patients were randomized. One GIST patient consented but had an adverse event and was withdrawn from the study before they were randomised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cediranib 45 mg/Day GIST | 26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient. |
| FG001 | Cediranib 45 mg/Day STS | 10 Soft Tissue Sarcomas (STS) patients were randomised. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cediranib 45 mg/Day GIST | Cediranib 45 mg/Day: 25 patients with Gastrointestinal Stromal Tumour (GIST) randomised |
| BG001 | Cediranib 45 mg/Day STS | Cediranib 45 mg/Day: 10 patients with Soft Tissue Sarcomas (STS) randomised |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age at informed consent |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients. | [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. | 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). | Posted | Mean | 95% Confidence Interval | g/mL | Baseline and 8 days after dosing. |
|
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Adverse events are reported for randomised patients who received at least one dose of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cediranib 45 mg/Day GIST | Cediranib 45 mg/Day patients with Gastrointestinal Stromal Tumour (GIST): 24 patients randomised and received at least one dose of treatment (1 patient was not randomised or dosed and a further 1 patient was randomised but not dosed due to Incorrect enrolmentCediranib) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D012509 | Sarcoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| C500926 | cediranib |
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| -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images. | 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. | 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. | 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. | 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 |
| Sutton |
| United Kingdom |
| Condition under investigation worsened |
|
| Incorrect enrollment |
|
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Gender at informed consent | Count of Participants | Participants |
|
| OG001 | Cediranib 45 mg/Day STS | Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment |
|
|
| 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. | SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients | 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). | Posted | Mean | 95% Confidence Interval | g/mL | FDG-PET assessment at Baseline and 29 days after dosing. |
|
|
|
| Secondary | Objective Tumour Response, Investigator Review | 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. | Posted | Number | Participants | RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression. |
|
|
|
| Secondary | -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images. | 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. | 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). | Posted | Mean | 95% Confidence Interval | mm | CT assessments at Baseline and Week 8 |
|
|
|
| Secondary | Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images. | 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. | 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). | Posted | Mean | 95% Confidence Interval | mm | CT assessments at Baseline and Week 16. |
|
|
|
| Secondary | Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images. | Central review of CT images taking the total lesion volume at week 8 minus the total lesion volume at baseline. | 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). | Posted | Mean | 95% Confidence Interval | cm3 | CT assessments at Baseline and Week 8 |
|
|
|
| Secondary | Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images. | Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline. | 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). | Posted | Mean | 95% Confidence Interval | cm3 | CT assessments at Baseline and Week 16 |
|
|
|
| 10 |
| 24 |
| 24 |
| 24 |
| EG001 | Cediranib 45 mg/Day STS | Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment. | 3 | 10 | 10 | 10 |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic Haemorrhage | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertensive Crisis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Splinter Haemorrhages | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mouth Haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Gastric Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Tooth Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Weight Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pharyngeal Erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skin Haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Subcutaneous Nodule | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |