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To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | AZD6244 in combination with dacarbazine |
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| 2 | Placebo Comparator | Placebo in combination with dacarbazine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6244 | Drug | oral capsules, 75mg twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first. | From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Middleton, Dr | Churchil Hospital, Oxford, UK | Principal Investigator |
| Caroline Robert, Dr | Institute Gustave Roussy, France | Principal Investigator |
| Ian Smith, Dr | AstraZeneca, Alderley Park, UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aurora | Colorado | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23735514 | Derived | Robert C, Dummer R, Gutzmer R, Lorigan P, Kim KB, Nyakas M, Arance A, Liszkay G, Schadendorf D, Cantarini M, Spencer S, Middleton MR. Selumetinib plus dacarbazine versus placebo plus dacarbazine as first-line treatment for BRAF-mutant metastatic melanoma: a phase 2 double-blind randomised study. Lancet Oncol. 2013 Jul;14(8):733-40. doi: 10.1016/S1470-2045(13)70237-7. Epub 2013 Jun 2. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Selumetinib 75mg BD +Dacarbazine | selumetinib 75mg twice daily + Dacarbazine |
| FG001 | Placebo BD + Dacarbazine | Placebo twice daily + Dacarbazine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dacarbazine | Drug | 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle |
|
|
| Placebo | Drug | Placebo |
|
| From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment |
| Objective Response Rate | ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR | From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment |
| Change in Target Lesion Tumour Size at Week 12 | randomization to week 12 |
| Boston |
| Massachusetts |
| United States |
| Research Site | Belo Horizonte | Brazil |
| Research Site | Ijuí | Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | São Paulo | Brazil |
| Research Site | Brno | Czechia |
| Research Site | Nový Jičín | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Lille | France |
| Research Site | Marseille | France |
| Research Site | Villejuif | France |
| Research Site | Berlin | Germany |
| Research Site | Essen | Germany |
| Research Site | Hanover | Germany |
| Research Site | Kiel | Germany |
| Research Site | Tübingen | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Amsterdam | Netherlands |
| Research Site | Nijmegen | Netherlands |
| Research Site | Oslo | Norway |
| Research Site | Barcelona | Spain |
| Research Site | Houston | Spain |
| Research Site | Málaga | Spain |
| Research Site | Palma de Mallorca | Spain |
| Research Site | Gothenburg | Sweden |
| Research Site | Malmö | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Zurich | Switzerland |
| Research Site | Cambridge | United Kingdom |
| Research Site | Chelmsford | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Newcastle upon Tyne | United Kingdom |
| Research Site | Oxford | United Kingdom |
| Research Site | Sutton | United Kingdom |
| D1532C00006.pdf | View source |
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Selumetinib 75mg BD +Dacarbazine | selumetinib 75mg twice daily + Dacarbazine |
| BG001 | Placebo BD + Dacarbazine | Placebo twice daily + Dacarbazine |
| 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 | Overall Survival | Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first. | Intention to Treat (ITT) | Posted | Median | Full Range | Days | From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. | Intention to Treat (ITT) | Posted | Median | Full Range | Days | From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR | Intention to Treat (ITT) | Posted | Number | Participants | From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Target Lesion Tumour Size at Week 12 | Intention to Treat (ITT) | Posted | Median | Full Range | % change | randomization to week 12 |
|
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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 | Selumetinib 75mg BD +Dacarbazine | selumetinib 75mg twice daily + Dacarbazine | 22 | 44 | 44 | 44 | ||
| EG001 | Placebo BD + Dacarbazine | Placebo twice daily + Dacarbazine | 8 | 45 | 44 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erysipelas | Infections and infestations | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment |
| ||
| Device related infection | Infections and infestations | Non-systematic Assessment |
| ||
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Lower respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Neutropenic sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Arterial thrombosis limb | Vascular disorders | Non-systematic Assessment |
| ||
| Venous thrombosis limb | Vascular disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Left atrial dilatation | Cardiac disorders | Non-systematic Assessment |
| ||
| Periorbital oedema | Eye disorders | Non-systematic Assessment |
| ||
| Ocular hypertension | Eye disorders | Non-systematic Assessment |
| ||
| Retinal tear | Eye disorders | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Groin Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Renal colic | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Prostatitis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Completed suicide | Psychiatric disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| LEUKOPENIA | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| NEUTROPENIA | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| EYELID OEDEMA | Eye disorders | Non-systematic Assessment |
| ||
| PERIORBITAL OEDEMA | Eye disorders | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DIARRHOEA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DRY MOUTH | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| DYSPEPSIA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| STOMATITIS | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| ASTHENIA | General disorders | Non-systematic Assessment |
| ||
| CHILLS | General disorders | Non-systematic Assessment |
| ||
| FACE OEDEMA | General disorders | Non-systematic Assessment |
| ||
| FATIGUE | General disorders | Non-systematic Assessment |
| ||
| GENERALISED OEDEMA | General disorders | Non-systematic Assessment |
| ||
| LOCALISED OEDEMA | General disorders | Non-systematic Assessment |
| ||
| OEDEMA PERIPHERAL | General disorders | Non-systematic Assessment |
| ||
| PYREXIA | General disorders | Non-systematic Assessment |
| ||
| FOLLICULITIS | Infections and infestations | Non-systematic Assessment |
| ||
| NASOPHARYNGITIS | Infections and infestations | Non-systematic Assessment |
| ||
| PARONYCHIA | Infections and infestations | Non-systematic Assessment |
| ||
| RASH PUSTULAR | Infections and infestations | Non-systematic Assessment |
| ||
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Non-systematic Assessment |
| ||
| URINARY TRACT INFECTION | Infections and infestations | Non-systematic Assessment |
| ||
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | Systematic Assessment |
| ||
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | Non-systematic Assessment |
| ||
| BLOOD CREATININE PHOSPHOKINASE INCREASED | Investigations | Non-systematic Assessment |
| ||
| BLOOD PRESSURE INCREASED | Investigations | Non-systematic Assessment |
| ||
| WEIGHT INCREASED | Investigations | Non-systematic Assessment |
| ||
| DECREASED APPETITE | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| HYPOKALAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| BACK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| MYALGIA | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| DIZZINESS | Nervous system disorders | Non-systematic Assessment |
| ||
| DYSGEUSIA | Nervous system disorders | Non-systematic Assessment |
| ||
| HEADACHE | Nervous system disorders | Non-systematic Assessment |
| ||
| LETHARGY | Nervous system disorders | Non-systematic Assessment |
| ||
| PARAESTHESIA | Nervous system disorders | Non-systematic Assessment |
| ||
| SYNCOPE | Nervous system disorders | Non-systematic Assessment |
| ||
| ANXIETY | Psychiatric disorders | Non-systematic Assessment |
| ||
| BRADYPHRENIA | Psychiatric disorders | Non-systematic Assessment |
| ||
| DEPRESSION | Psychiatric disorders | Non-systematic Assessment |
| ||
| INSOMNIA | Psychiatric disorders | Non-systematic Assessment |
| ||
| COUGH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| DRY SKIN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| ECZEMA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| ERYTHEMA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| HAIR COLOUR CHANGES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| SKIN CHAPPED | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| SKIN FISSURES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| HYPERTENSION | Vascular disorders | Non-systematic Assessment |
| ||
| LYMPHOEDEMA | Vascular disorders | Non-systematic Assessment |
| ||
| ALOPECIA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriella Mariani | AstraZeneca | +44 7818 523 899 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C517975 | AZD 6244 |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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