Not provided
Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT02533258 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.
This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Axitinib Treatment | From initiation of axitinib treatment up to the end of the study (up to 40 months) | |
| Mean Daily Dose of Axitinib | From initiation of axitinib treatment up to the end of the study (up to 40 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than [<]10 millimeter [mm] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
advanced renal cell carinoma with disease progression on sunitinib or interferon
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Axitinib (INLYTA) | Participants diagnosed with advanced renal cell carcinoma (RCC) and received axitinib therapy as per routine clinical practice according to the label-packaging-dosing (LPD) under the physician's prescription were observed for 40 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all the enrolled participants who received at least one dose of the axitinib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Axitinib (INLYTA) | Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Duration of Axitinib Treatment | Efficacy population included all the participants who were enrolled in the study. | Posted | Median | 95% Confidence Interval | months | From initiation of axitinib treatment up to the end of the study (up to 40 months) |
|
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Axitinib (INLYTA) | Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dissecting aortic aneurysm type B | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
| From initiation of axitinib treatment until PD or death from any cause (up to 40 months) |
| Duration of Response | Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as >=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. | From initiation of axitinib treatment until PD or death from any cause (up to 40 months) |
| Progression-Free Survival (PFS) | PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as >=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated. | From initiation of axitinib treatment until PD or death from any cause (up to 40 months) |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non--serious events. | From initiation of axitinib treatment up to end of the study (up to 40 months) |
| Number of Participants With Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE. | From initiation of axitinib treatment up to end of the study (up to 40 months) |
| Number of Participants With Treatment-Related Adverse Events (AEs) | A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | From initiation of axitinib treatment up to end of the study (up to 40 months) |
| Number of Participants Discontinued Due to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | From initiation of axitinib treatment up to end of the study (up to 40 months) |
| Economic factor |
|
| Progression of pleural effusion |
|
| Lack of Efficacy |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Mean Daily Dose of Axitinib | Efficacy population included all the participants who were enrolled in the study. | Posted | Mean | Standard Deviation | milligram | From initiation of axitinib treatment up to the end of the study (up to 40 months) |
|
|
|
| Secondary | Objective Response Rate (ORR) | ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than [<]10 millimeter [mm] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment. | Efficacy population included all the participants who were enrolled in the study. | Posted | Number | percentage of participants | From initiation of axitinib treatment until PD or death from any cause (up to 40 months) |
|
|
|
| Secondary | Duration of Response | Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as >=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. | Efficacy population included all the participants who were enrolled in the study. Here 'number of participants analyzed' signifies participants who achieved a confirmed CR or PR. | Posted | Median | 95% Confidence Interval | months | From initiation of axitinib treatment until PD or death from any cause (up to 40 months) |
|
|
|
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as >=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated. | Efficacy population included all the participants who were enrolled in the study. | Posted | Median | 95% Confidence Interval | months | From initiation of axitinib treatment until PD or death from any cause (up to 40 months) |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non--serious events. | Safety population included all the enrolled participants who received at least one dose of the axitinib. | Posted | Number | participants | From initiation of axitinib treatment up to end of the study (up to 40 months) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE. | Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | participants | From initiation of axitinib treatment up to end of the study (up to 40 months) |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events (AEs) | A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | participants | From initiation of axitinib treatment up to end of the study (up to 40 months) |
|
|
|
| Secondary | Number of Participants Discontinued Due to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | partcicipants | From initiation of axitinib treatment up to end of the study (up to 40 months) |
|
|
|
| 2 |
| 13 |
| 10 |
| 13 |
| Weight decreased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Hernia | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|