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| Name | Class |
|---|---|
| International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) | OTHER |
| Analysis Group, Inc. | INDUSTRY |
The study aims to assess clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with mRCC | Patients diagnosed with metastatic RCC receiving first line (1L) combination of IOs therapies followed by Sunitinib as a second line (2L) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib | Drug | Patients to receive sunitinib as second line therapy for mRCC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy | Overall survival was defined as the time (in months) from second line sunitinib initiation to death. Participants were censored at their date of last follow-up. Kaplan-Meier method was used for analysis. | From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
| Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy | TTD was defined as the time (in months) between initiation of second line sunitinib therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis. | From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
| Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy | TTD was defined as the time (in months) between initiation of first line Immune-Oncologic therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis. | From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years) |
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria:
None
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patients with diagnosis of mRCC who initiated sunitinib as 2nd line treatment
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | p2n 4n2 | Canada |
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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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In this study, data for participants was collected retrospectively through the international mRCC database consortium (IMDC) database. Data was collected and analyzed during study duration of approximately 4 months.
Participants included in this study, were diagnosed with metastatic renal cell carcinoma (mRCC), who were treated with sunitinib from 2014 to 2019, after first-line immune-oncologic therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib Following Immune-oncologic Therapy | Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data was collected and analyzed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib Following Immune-oncologic Therapy | Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy | Overall survival was defined as the time (in months) from second line sunitinib initiation to death. Participants were censored at their date of last follow-up. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data was collected and analyzed in this study. | Posted | Median | 95% Confidence Interval | Months | From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
Not applicable as adverse events not collected during the study
Due to the nature of claims database from which data were queried, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) would not meet, hence safety data was not planned to be collected and reported.
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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 | Sunitinib Following Immune-oncologic Therapy | Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Oct 21, 2019 | Mar 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation | Reasons for treatment discontinuation included disease progression, death, toxicity and other reasons including urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified. As per RECIST v1.1. criteria, disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. | From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
| Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy | The objective response rate was defined as the percentage of participants with partial response (PR) and complete response (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 normalisation of tumour 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. | From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
| Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy | Progressive disease (PD) was defined as an increase in visible disease. According to RECIST 1.1; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. | From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
| Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy | Stable disease was defined as no change in size of visible disease. According to RECIST 1.1, stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease , taking as reference the smallest sum diameters while on study; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. | From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
| Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy | From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years) |
| Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation | Reasons for treatment discontinuation included disease progression, toxicity and other reasons including itchiness, mouth dryness, comorbidity, and other unspecified. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. | From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Prior Nephrectomy Status | Here, number of participants with their previous nephrectomy status as "Yes" or "No" are reported. | Count of Participants | Participants |
|
| Histology Type | Here, number of participants with histology type as "Clear cell" or "Non-clear cell" are reported. | Here 'number analyzed" signifies participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Metastatic Sites | Here, number of participants are classified according to number of metastatic sites. | Here 'number analyzed" signifies participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Site of Metastases | Here, number of participants are classified according to type of metastatic sites. | Here 'Number analyzed" signifies participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Participants According to Time From RCC Diagnosis to First Line Therapy | Here, number of participants are classified according to duration of RCC diagnosis to first line therapy. | Count of Participants | Participants |
|
| Karnofsky Performance Status (KPS) | KPS is a standard way of measuring the ability of participants with cancer to perform ordinary tasks. KPS scores range from 0 percent (%) (dead) to 100% (normal, no complaints). A higher score means the participant is better able to carry out daily activities. Here, number of participants are classified with KPS score of <80% and >=80%. | Here 'number analyzed" signifies participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Hemoglobin Level | Here, number of participants are classified with hemoglobin level < lower limit normal (LLN) and >= LLN. | Here 'number analyzed" signifies participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Serum Corrected Calcium Level | Here, number of participants are classified with serum corrected calcium level > upper limit normal (ULN) and <= ULN. | Here 'number analyzed" signifies participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Neutrophil Count | Here, number of participants are classified with neutrophil count > ULN and <= ULN. | Here 'number analyzed" signifies participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Platelets Count | Here, number of participants are classified with platelets count > ULN and <= ULN. | Here 'number analyzed" signifies participants evaluable for this baseline measure. | Count of Participants | Participants |
|
|
|
| Primary | Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy | TTD was defined as the time (in months) between initiation of second line sunitinib therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data was collected and analyzed in this study. | Posted | Median | 95% Confidence Interval | Months | From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
|
|
| Primary | Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy | TTD was defined as the time (in months) between initiation of first line Immune-Oncologic therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis. | Analysis population included all eligible participants whose data was collected and analyzed in this study. | Posted | Mean | Standard Deviation | Months | From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years) |
|
|
|
| Primary | Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation | Reasons for treatment discontinuation included disease progression, death, toxicity and other reasons including urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified. As per RECIST v1.1. criteria, disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. | Analysis population included all eligible participants whose data was collected and analyzed in this study. Here, "Overall Number of Participants Analyzed" signifies participants who discontinued second line sunitinib treatment. | Posted | Count of Participants | Participants | From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
|
|
| Primary | Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy | The objective response rate was defined as the percentage of participants with partial response (PR) and complete response (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 normalisation of tumour 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. | Analysis population included all eligible participants whose data was collected and analyzed in this study. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
|
|
| Primary | Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy | Progressive disease (PD) was defined as an increase in visible disease. According to RECIST 1.1; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. | Analysis population included all eligible participants whose data was collected and analyzed in this study. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
|
|
| Primary | Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy | Stable disease was defined as no change in size of visible disease. According to RECIST 1.1, stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease , taking as reference the smallest sum diameters while on study; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. | Analysis population included all eligible participants whose data was collected and analyzed in this study. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months) |
|
|
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| Primary | Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy | Analysis population included all eligible participants whose data was collected and analyzed in this study. | Posted | Mean | Standard Deviation | Months | From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years) |
|
|
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| Primary | Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation | Reasons for treatment discontinuation included disease progression, toxicity and other reasons including itchiness, mouth dryness, comorbidity, and other unspecified. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. | Analysis population included all eligible participants whose data was collected and analyzed in this study. | Posted | Count of Participants | Participants | From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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 |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Disease progression and Toxicity |
|
| Disease progression and Death |
|
| Other (urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified) |
|
| Other (itchiness, mouth dryness, comorbidity, and other unspecified) |
|