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The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease.
This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine.
All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD).
This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people:
This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.
This study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic Renal Cell Carcinoma with Sunitinib First-Line Therapy based on data extracted and analyzed from the RCC Registry.
The annual disease burden in contributing centers to RCC Registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. Therefore, it is estimated that information of approximately 400 eligible patients who were registered in RCC Registry from 2019 to 2022 will be included in the analysis.
RCC Registry will be used as the sole data source for this study. For this purpose, no Case Report Forms (CRFs) or Data Collection Tools (DCTs) will be utilized, but the RCC Registry database will be used directly. Eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metastatic Renal Cell Carcinoma patients | metastatic Renal Cell Carcinoma patients with clear cell histology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | as provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) According to Disease Risk Group in IMDC | ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (RECIST)1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum calcium [Ca]; neutrophils and platelets >ULN; hemoglobin [hg] \ | From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| Response Rates According to Disease Risk Group in IMDC | RECIST1.1- CR: disappearance of all lesions & normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca]; neutrophils & platelets >ULN; hg \ | From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Rate According to Disease Risk Group in IMDC | OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca; neutrophils and platelets >ULN; hg \ |
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Inclusion Criteria:
Exclusion Criteria:
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RCC Registry will be screened for all patients who meets all inclusion criteria and who doesn't meet the exclusion criterion defined in the study protocol and who were treated with Sunitinib in first-line therapy for mRCC and were registered to the database between 2019 and 2022.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Istanbul | 34394 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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RCC registry was a data log where clinical information was recorded by inviting participants who met the selection criteria according to protocol (Turkish citizen, older than 18 years, being diagnosed with mRCC and being treated with sunitinib in first line). It was used as data source for this study and the participant data was retrospectively recorded in the study database. A total of 376 participants were included in this study which pulled out records from the RCC registry.
Participants with metastatic renal cell carcinoma (mRCC), who were being treated with Sunitinib in first-line therapy and got registered in RCC database between 01-March-2019 and 30-October-2022 were included in this study and their data was observed retrospectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | Participants diagnosed with mRCC, who were being treated with Sunitinib as first-line therapy in real world practice and who got registered in RCC registry in Turkey were included. The recommended dose of sunitinib in mRCC is 50 milligrams (mg) orally daily for 4 weeks, followed by 2 weeks off treatment (4/2 schedule). |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2022 |
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| ORR According to Disease Risk Group in MSKCC | ORR: percentage of participants with PR and CR. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. MSKCC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL]. | From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| Response Rates According to Disease Risk Group in MSKCC | RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL]. | From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| Progression-Free Survival (PFS) According to Disease Risk Group in IMDC | PFS: duration from start of treatment to disease progression (PD), end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca; neutrophils and platelets >ULN; hg \ | From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| OS According to Disease Risk Group in MSKCC | OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL]. | From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| PFS According to Disease Risk Group in MSKCC | PFS: duration from start of treatment to PD, end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL]. | From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| COMPLETED |
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| NOT COMPLETED |
|
Analysis population included all eligible participants whose data were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | Participants diagnosed with mRCC on treatment with Sunitinib as first-line therapy in real world practice and were registered in RCC registry in Turkey were included. The recommended dose of sunitinib in mRCC is 50 mg orally daily for 4 weeks, followed by 2 weeks off treatment (4/2 schedule). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Number of Participants With Comorbidities | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Participants According to Previous Nephrectomy Status | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Participants According to Previous Interferon Use | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups | IMDC criteria had 6 risk factors: Karnofsky Performance Status (KPS) less than (<) 80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <1 year; corrected serum calcium; neutrophils and platelets more than (>) upper limit of normal (ULN); hemoglobin <lower limit of normal (LLN). Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (more than or equal to [>=]3 factors). | Count of Participants | Participants |
| |||||||||||||||||
| Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups | MSKCC criteria had 5 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; hemoglobin <LLN; lactate dehydrogenase 1.5*ULN; corrected serum calcium >10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors). | Count of Participants | Participants |
| |||||||||||||||||
| Number of Participants According to Metastatic Sites | Participants could have more than 1 metastatic sites. | Count of Participants | Participants |
| |||||||||||||||||
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2: ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours, Grade 3: capable of only limited self-care, confined to bed or chair for more than 50% of waking hours, Grade 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair. | Count of Participants | Participants |
| |||||||||||||||||
| Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage | 0= tumor is 7 centimeter (cm) across, is only in kidney and has not spread; 1= tumor is larger than 7 cm across, is only in kidney and has not spread; 2= tumor grown into a major vein, not growing into adrenal gland or beyond Gerota's fascia and has not spread; 3= tumor is of any size, not spread beyond Gerota's fascia and has not spread; 4= tumor is growing beyond Gerota's fascia and may/may not has spread. The higher the number, the larger the tumor and/or the more it has spread into nearby tissues. | 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 | Objective Response Rate (ORR) According to Disease Risk Group in IMDC | ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (RECIST)1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum calcium [Ca]; neutrophils and platelets >ULN; hemoglobin [hg] \ | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signified participants who were evaluable for this outcome measure and with non-missing data; "Number Analyzed" signified participants evaluable for specified rows. | Posted | Number | Percentage of participants | From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
|
|
| ||||||||||||||||||||||||||||
| Primary | Response Rates According to Disease Risk Group in IMDC | RECIST1.1- CR: disappearance of all lesions & normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca]; neutrophils & platelets >ULN; hg \ | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signified participants who were evaluable for this outcome measure and with non-missing data; "Number Analyzed" signified participants evaluable for specified rows. | Posted | Number | Percentage of participants | From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| ||||||||||||||||||||||||||||||
| Primary | ORR According to Disease Risk Group in MSKCC | ORR: percentage of participants with PR and CR. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. MSKCC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL]. | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signified participants who were evaluable for this outcome measure and with non-missing data; "Number Analyzed" signified participants evaluable for specified rows. | Posted | Number | Percentage of participants | From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
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| Primary | Response Rates According to Disease Risk Group in MSKCC | RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL]. | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signified participants who were evaluable for this outcome measure and with non-missing data; "Number Analyzed" signified participants evaluable for specified rows. | Posted | Number | Percentage of participants | From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Rate According to Disease Risk Group in IMDC | OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca; neutrophils and platelets >ULN; hg \ | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signified participants with non-missing data and "Number Analyzed" signified participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
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| Secondary | Progression-Free Survival (PFS) According to Disease Risk Group in IMDC | PFS: duration from start of treatment to disease progression (PD), end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca; neutrophils and platelets >ULN; hg \ | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signified participants with non-missing data and "Number Analyzed" signified participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
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| Secondary | OS According to Disease Risk Group in MSKCC | OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL]. | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signified participants with non-missing data and "Number Analyzed" signified participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
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| Secondary | PFS According to Disease Risk Group in MSKCC | PFS: duration from start of treatment to PD, end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL]. | Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signified participants with non-missing data and "Number Analyzed" signified participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] |
|
Not applicable as adverse events were not planned to be collected during the study.
Minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not collected and reported.
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 | Sunitinib | Participants diagnosed with mRCC on treatment with Sunitinib as first-line therapy in real world practice and were registered in RCC registry in Turkey were included. The recommended dose of sunitinib in mRCC is 50 mg orally daily for 4 weeks, followed by 2 weeks off treatment (4/2 schedule). | 0 | 0 | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Inc. | Pfizer ClinicalTrials.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Feb 23, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| C538445 | Clear-cell metastatic renal cell carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| 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 |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
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| Missing |
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| Intermediate |
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| Poor |
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| Missing |
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| Intermediate |
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| Poor |
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| Missing |
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| Bone |
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| Liver |
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| Central Nervous System |
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| 2 |
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| 3-4 |
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| Missing |
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| 2 |
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| 3 |
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| 4 |
|
| Missing |
|
|
| Poor |
|
|
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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