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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000368-17 | EudraCT Number |
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The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dovitinib | Experimental | Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). |
|
| dovitinib + fulvestrant | Experimental | Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dovitinib | Drug | Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events of Grades 3 and 4 Severity | Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row. | Until the last patient discontinued dovitinib up to 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Las Vegas | Nevada | 89169 | United States | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| ID | Title | Description |
|---|---|---|
| FG000 | Dovitinib | Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| fulvestrant | Drug | Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution. |
|
| The Bronx |
| New York |
| 10467-2490 |
| United States |
| Novartis Investigative Site | Salzburg | 5020 | Austria |
| Novartis Investigative Site | Wilrijk | 2610 | Belgium |
| Novartis Investigative Site | Copenhagen | DK-2100 | Denmark |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Torino | TO | 10153 | Italy |
| Novartis Investigative Site | Osaka | Osaka | 545-8586 | Japan |
| Novartis Investigative Site | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Dovitinib + Fulvestrant |
Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB. |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS): all patients who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dovitinib | Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). |
| BG001 | Dovitinib + Fulvestrant | Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB. |
| 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 | Number of Participants With Adverse Events of Grades 3 and 4 Severity | Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row. | Safety set: the Safety set included all patients who received at least one dose of study medication. Safety set was identical to Full Analysis Set for this study. | Posted | Count of Participants | Participants | Until the last patient discontinued dovitinib up to 30 months |
|
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Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 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 | Dovitinib | Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). | 4 | 10 | 9 | 10 | ||
| EG001 | Dovitinib+Fulvestrant | Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). | 2 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| ANGINA PECTORIS | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
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| EYE OEDEMA | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (19.1) | Systematic Assessment |
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| FACE OEDEMA | General disorders | MedDRA (19.1) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (19.1) | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA (19.1) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (19.1) | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| NEURALGIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| RESTLESSNESS | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| SEBACEOUS GLAND DISORDER | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C500007 | 4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Male |
|
| Cardiac disorders |
|
| Ear and Labyrinth disorders |
|
| Endocrine disorders |
|
| Eye disorders |
|
| Gastrointestinal disorders |
|
| General disorders & administration site conditions |
|
| Infections and Infestations |
|
| Injury, poisoning and procedural complications |
|
| Investigations |
|
| Metabolism and nutrition Disorders |
|
| Musculoskeletal and connective tissue disorders |
|
| Neoplasms benign, malignant & Unspecified |
|
| Nervous system Disorders |
|
| Psychiatric disorders |
|
| Respiratory, thoracic and mediastinal disorders |
|
| Skin and subcutaneous tissue disorders |
|
| Vascular disorders |
|