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Primary objective of the trial was not met and so there was no benefit in collecting further information
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| Name | Class |
|---|---|
| ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI | UNKNOWN |
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The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZD4054 + paclitaxel + carboplatin | Experimental | ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks |
|
| Placebo + paclitaxel + carboplatin | Placebo Comparator | Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD4054 Zibotentan | Drug | 10 mg oral tablets once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. | Patients were followed for progression up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Median time (in months) from randomisation until death using the Kaplan-Meier method. | Patients were followed for survival up to 2 years |
| Tumour Response Rate | Objective response rate defined as participants with a complete or partial response according to RECIST |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Morris | AstraZeneca, Alderley Park | Study Director |
| Ian Thomas | AstraZeneca, Alderley Park | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23234805 | Derived | Cognetti F, Bagnato A, Colombo N, Savarese A, Scambia G, Sehouli J, Wimberger P, Sorio R, Harter P, Mari E, McIntosh S, Nathan F, Pemberton K, Baumann K. A Phase II, randomized, double-blind study of zibotentan (ZD4054) in combination with carboplatin/paclitaxel versus placebo in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to platinum-based chemotherapy (AGO-OVAR 2.14). Gynecol Oncol. 2013 Jul;130(1):31-7. doi: 10.1016/j.ygyno.2012.12.004. Epub 2012 Dec 9. |
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12 of the 132 enrolled patients were not randomised to treatment groups as they failed screening
132 patients with advanced ovarian cancer sensitive to platinum-based chemotherapy were recruited between 26th June 2009 and 1st June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | ZD4054+Paclitaxel+Carboplatin | ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks |
| FG001 | Placebo+Paclitaxel+Carboplatin | Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paclitaxel |
| Drug |
175mg/m2 IV on day 1 every 3 weeks |
|
| Carboplatin | Drug | Carboplatin AUC of 5.0 IV on day 1 every 3 weeks |
|
| Placebo | Drug | matching placebo for ZD4054 10 mg |
|
| While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years) |
| Dresden |
| Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Essen | Germany |
| Research Site | Karlsruhe | Germany |
| Research Site | Kassel | Germany |
| Research Site | Kiel | Germany |
| Research Site | Lich | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Marburg | Germany |
| Research Site | München | Germany |
| Research Site | Rostock | Germany |
| Research Site | Wiesbaden | Germany |
| Research Site | Milan | MI | Italy |
| Research Site | Perugia | PG | Italy |
| Research Site | Aviano | PN | Italy |
| Research Site | Roma | Roma | Italy |
| Research Site | Campobasso | Italy |
| Research Site | Modena | Italy |
| Research Site | Naples | Italy |
| Patients Who Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ZD4054+Paclitaxel+Carboplatin | ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks |
| BG001 | Placebo+Paclitaxel+Carboplatin | Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks |
| BG002 | 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | 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 | Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. | Posted | Median | Inter-Quartile Range | Months | Patients were followed for progression up to 2 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Median time (in months) from randomisation until death using the Kaplan-Meier method. | Overall Survival was not analysed as the study was terminated early. | Posted | Patients were followed for survival up to 2 years |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Tumour Response Rate | Objective response rate defined as participants with a complete or partial response according to RECIST | The number of participants for analysis corresponds to patients with measurable disease at study entry | Posted | Number | Participants | While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years) |
|
|
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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 | ZD4054+Paclitaxel+Carboplatin | ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks | 19 | 58 | 57 | 58 | ||
| EG001 | Placebo+Paclitaxel+Carboplatin | Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks | 13 | 58 | 58 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrointestinal Toxicity | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Escherichia Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin Decreased | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Ovarian Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Salivary Gland Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vena Cava Thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
AstraZeneca can review results communications prior to public release and may within 60 days of receipt require amendments to be made. AstraZeneca can also require that submission or disclosure be delayed to allow for the filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C511404 | ZD4054 |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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| Male |
|
|