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This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it's better than giving standard treatment alone in helping to prevent progression of mCRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX + Cediranib 20 mg | Active Comparator | FOLFOX + Cediranib 20 mg |
|
| FOLFOX + Cediranib 30 mg | Active Comparator | FOLFOX + Cediranib 30 mg |
|
| FOLFOX + Placebo Cediranib | Placebo Comparator | FOLFOX + Placebo Cediranib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2171 | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. | RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumour Response Rate | Number of patients with complete (CR) /partial response (PR) (based on RECIST). 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 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson | AstraZeneca | Study Director |
| Hideyuki Mishima, M.D., PhD | National Hospital Organization Osaka National Hospital | Principal Investigator |
| Xiaojin Shi, MD | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Osaka | Japan | ||||
| Research Site |
Not provided
| Label | URL |
|---|---|
| CSR-D8480C00039.pdf | View source |
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PFS & OS: median based on Kaplan Meier analysis (i.e. adjusted for censored observations) but full range based on raw data (i.e. not adjusted for censored observations). OS: median non-estimable due to censored observations
Randomised=ITT=Safety: Cediranib 20mg=58, Cediranib 30mg=56, Placebo=58
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| ID | Title | Description |
|---|---|---|
| FG000 | Cediranib 20 mg | FOLFOX + Cediranib 20 mg |
| FG001 | Cediranib 30 mg | FOLFOX + Cediranib 30 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) | Drug | intravenous infusion |
|
|
| Placebo Cediranib | Drug | oral tablet |
|
| Best Percentage Change in Tumour Size | Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions | Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups) |
| Duration of Response | Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups). | RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) |
| Overall Survival | Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored. | Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups) |
| Saitama |
| Japan |
| FG002 |
| Placebo |
FOLFOX + Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cediranib 20 mg | FOLFOX + Cediranib 20 mg |
| BG001 | Cediranib 30 mg | FOLFOX + Cediranib 30 mg |
| BG002 | Placebo | FOLFOX + Placebo |
| BG003 | Total | Total of all reporting groups |
| 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 | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Gender at informed consent | Count of Participants | Participants |
|
| 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 | Progression Free Survival | Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. | Posted | Median | Full Range | Months | RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Objective Tumour Response Rate | Number of patients with complete (CR) /partial response (PR) (based on RECIST). 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 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Best Percentage Change in Tumour Size | Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions | Posted | Mean | Standard Deviation | Percentage | Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups). | Posted | Mean | Standard Deviation | Months | RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored. | Posted | Median | Full Range | Months | Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups) |
|
|
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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 20 mg | Cediranib 20 mg | 23 | 58 | 58 | 58 | ||
| EG001 | Cediranib 30 mg | Cediranib 30 mg | 22 | 56 | 56 | 56 | ||
| EG002 | Placebo | Placebo | 11 | 58 | 58 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Prinzmetal Angina | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Anal Haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Duodenal Perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Mesenteric Artery Thrombosis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Anaphylactic Shock | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Altered State Of Consciousness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Brain Stem Infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Reversible Posterior Leukoencephalopathy Syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypertension | 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 |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Anal Haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric 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 |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pigmentation Disorder | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Haemorrhage Subcutaneous | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C500926 | cediranib |
| C410216 | Folfox protocol |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Male |
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