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This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental | Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Administered by subcutaneous injection every 4 weeks (Q4W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product. | From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-denosumab Binding Antibodies | A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies. | Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Capital Federal | Buenos Aires | C1426ANZ | Argentina | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
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This study was conducted at 65 centers in Europe, Latin America, Japan, and South Africa. Participants were enrolled from 22 November 2011 to 27 October 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab | Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2013 | Aug 1, 2019 |
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| Quilmes |
| Buenos Aires |
| B1878GEG |
| Argentina |
| Research Site | Córdoba | Córdoba Province | X5016KEH | Argentina |
| Research Site | Rosario | Santa Fe Province | S2000PBJ | Argentina |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Namur | 5000 | Belgium |
| Research Site | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Research Site | Santo André | São Paulo | 09060-650 | Brazil |
| Research Site | São Paulo | São Paulo | 01221-020 | Brazil |
| Research Site | São Paulo | São Paulo | 01509-900 | Brazil |
| Research Site | São Paulo | São Paulo | 04262-000 | Brazil |
| Research Site | Sorocaba | São Paulo | 18030-200 | Brazil |
| Research Site | Rio de Janeiro | 20551-030 | Brazil |
| Research Site | Rio de Janeiro | 22640-000 | Brazil |
| Research Site | São Paulo | 01209-000 | Brazil |
| Research Site | Kroměříž | 767 55 | Czechia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Prague | 110 00 | Czechia |
| Research Site | Prague | 140 00 | Czechia |
| Research Site | Prague | 140 44 | Czechia |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Saint-Cloud | 92210 | France |
| Research Site | Debrecen | 4012 | Hungary |
| Research Site | Dombóvár | 7200 | Hungary |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Rehovot | 76100 | Israel |
| Research Site | Tel Aviv | 64239 | Israel |
| Research Site | Ẕerifin | 70300 | Israel |
| Research Site | Meldola (FC) | 47014 | Italy |
| Research Site | Sora | 03039 | Italy |
| Research Site | Kure-shi | Hiroshima | 737-0023 | Japan |
| Research Site | Kagoshima | Kagoshima-ken | 892-0833 | Japan |
| Research Site | Isehara-shi | Kanagawa | 259-1193 | Japan |
| Research Site | Osaka | Osaka | 540-0006 | Japan |
| Research Site | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Research Site | Chuo-ku | Tokyo | 104-0045 | Japan |
| Research Site | Tokyo | 135-8550 | Japan |
| Research Site | Daugavpils | 5417 | Latvia |
| Research Site | Riga | 1079 | Latvia |
| Research Site | Kaunas | 50009 | Lithuania |
| Research Site | Vilnius | 08660 | Lithuania |
| Research Site | Panama City | Panama |
| Research Site | Lima | Lima 18 | Peru |
| Research Site | Lima | Lima 27 | Peru |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Bydgoszcz | 85-171 | Poland |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Lublin | 20-954 | Poland |
| Research Site | Poznan | 61-866 | Poland |
| Research Site | Warsaw | 00-631 | Poland |
| Research Site | Arkhangelsk | 163045 | Russia |
| Research Site | Chelyabinsk | 454087 | Russia |
| Research Site | Krasnogorsky District | 143423 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Obninsk | 249036 | Russia |
| Research Site | Omsk | 644013 | Russia |
| Research Site | Saint Petersburg | 197089 | Russia |
| Research Site | Pretoria | 0081 | South Africa |
| Research Site | Seville | Andalusia | 41013 | Spain |
| Research Site | Valencia | Valencia | 46009 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Lviv | 79031 | Ukraine |
| Received Denosumab |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab | Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale. |
| 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 |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product. | All participants who received at least one dose of denosumab in study 20110113 | Posted | Count of Participants | Participants | From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-denosumab Binding Antibodies | A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies. | Participants who received at least 1 dose of denosumab in study 20110113 and with at least 1 antibody sample tested. | Posted | Count of Participants | Participants | Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months. |
|
|
From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Denosumab | Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale. | 18 | 128 | 45 | 128 | 66 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Myelitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac myxoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2018 | Aug 1, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| 75 - 84 years |
|
| ≥ 85 years |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Other |
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
| AE leading to discontinuation from study |
|
| Fatal adverse events |
|
| AE grade 3, 4, or 5 |
|
| Treatment-related adverse event |
|
| Treatment-related serious adverse event |
|
| TRAE leading to discontinuation of denosumab |
|
| TRAE leading to discontinuation from study |
|
| Treatment-related fatal adverse events |
|
| Treatment-related AE grade 3, 4, or 5 |
|
|