Renal Cell Carcinoma
Conditions
Brief summary
This study is a survey in Japan of Cabozantinib tablets used to treat people with a type of kidney cancer called renal cell carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with renal cell carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 26 weeks.
Detailed description
The drug being tested in this study is called cabozantinib tablets. This tablet is being tested to treat people who have radically unresectable or metastatic renal cell carcinoma. This study is an observational (non-interventional) study and will look at occurrence of adverse drug reactions (or adverse events) of cabozantinib tablets in the routine clinical setting. The planned number of observed patients will be approximately 300. This multi-center observational trial will be conducted in Japan.
Interventions
DRUGCabozantinib
Cabozantinib tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with radically unresectable or metastatic renal cell carcinoma who do not meet the following exclusion criterion are eligible.
Exclusion criteria
A patient who has a history of hypersensitivity to any component of cabozantinib.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib | Up to 26 weeks | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | Up to 26 weeks | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. |
| Number of Participants With Grade 3 or Higher Adverse Events | Up to 26 weeks | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| Percentage of Adverse Events Leading to Dose Changes of Cabozantinib | Up to 26 weeks | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Up to 26 weeks | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. |
| Number of Participants With Grade 3 or Higher Adverse Drug Reactions | Up to 26 weeks | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib | Up to 26 weeks | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. |
| Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | Up to 26 weeks | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. |
| Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | Up to 26 weeks | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib | Up to 26 weeks | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. |
| Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis | Up to 26 weeks | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug. |
| Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis | Up to 26 weeks | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve or Maintain Any Best Response | Up to 26 weeks | Best response was assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best response was defined as the level of best response in assessment with complete response (CR), partial response (PR) during the observational period. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 102 investigative sites in Japan, from 29 March 2021 to 25 July 2024.
Pre-assignment details
Participants with renal cell carcinoma who received Cabozantinib were enrolled. Participants received Cabozantinib as part of a routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Cabozantinib Monotherapy Participants with renal cell carcinoma who received Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks as part of routine medical care. | 322 |
| Cabozantinib + Nivolumab Combination Therapy Participants with renal cell carcinoma who received Cabozantinib 40 milligrams (mg) tablet, orally, once daily, and Nivolumab intravenous infusion as part of routine medical care. | 63 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Cabozantinib Monotherapy | Cabozantinib + Nivolumab Combination Therapy | Total |
|---|---|---|---|
| Age, Continuous | 68.7 Years STANDARD_DEVIATION 11.34 | 68.7 Years STANDARD_DEVIATION 11.55 | 68.7 Years STANDARD_DEVIATION 11.36 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 98 Participants | 17 Participants | 115 Participants |
| Sex: Female, Male Male | 224 Participants | 46 Participants | 270 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 322 | 5 / 63 |
| other Total, other adverse events | 165 / 322 | 24 / 63 |
| serious Total, serious adverse events | 73 / 322 | 28 / 63 |
Outcome results
Primary
Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cabozantinib Monotherapy | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | Adverse Drug Reaction of Hepatic Failure and Hepatic Dysfunction | 52 Participants |
| Cabozantinib Monotherapy | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | 2 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | Adverse Drug Reaction of Hepatic Failure and Hepatic Dysfunction | 16 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | Serious Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | 4 Participants |
Primary
Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cabozantinib Monotherapy | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis | Adverse Drug Reaction of Pancreatitis | 9 Participants |
| Cabozantinib Monotherapy | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis | Serious Adverse Drug Reactions of Pancreatitis | 4 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis | Adverse Drug Reaction of Pancreatitis | 3 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Adverse Drug Reaction and Serious Adverse Drug Reactions of Pancreatitis | Serious Adverse Drug Reactions of Pancreatitis | 1 Participants |
Primary
Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cabozantinib Monotherapy | Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Adverse Drug Reactions | 193 Participants |
| Cabozantinib Monotherapy | Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Serious Adverse Drug Reactions | 49 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Adverse Drug Reactions | 41 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Serious Adverse Drug Reactions | 18 Participants |
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cabozantinib Monotherapy | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | Adverse Events | 216 Participants |
| Cabozantinib Monotherapy | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | Serious Adverse Events | 73 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | Adverse Events | 46 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | Serious Adverse Events | 28 Participants |
Primary
Number of Participants With Grade 3 or Higher Adverse Drug Reactions
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib Monotherapy | Number of Participants With Grade 3 or Higher Adverse Drug Reactions | 80 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Grade 3 or Higher Adverse Drug Reactions | 24 Participants |
Primary
Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib Monotherapy | Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | 8 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction | 7 Participants |
Primary
Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib Monotherapy | Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis | 2 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Grade 3 or Higher Adverse Drug Reactions of Pancreatitis | 3 Participants |
Primary
Number of Participants With Grade 3 or Higher Adverse Events
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib Monotherapy | Number of Participants With Grade 3 or Higher Adverse Events | 103 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Number of Participants With Grade 3 or Higher Adverse Events | 29 Participants |
Primary
Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cabozantinib Monotherapy | Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib | 72.1 Percent of Adverse Drug Reactions |
| Cabozantinib + Nivolumab Combination Therapy | Percentage of Adverse Drug Reactions Leading to Dose Changes of Cabozantinib | 74.3 Percent of Adverse Drug Reactions |
Primary
Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cabozantinib Monotherapy | Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib | 77.0 Percent of Adverse Drug Reactions |
| Cabozantinib + Nivolumab Combination Therapy | Percentage of Adverse Drug Reactions of Hepatic Failure and Hepatic Dysfunction Leading to Dose Changes of Cabozantinib | 78.9 Percent of Adverse Drug Reactions |
Primary
Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any event that results in: death; life-threatening; requires inpatient hospitalisation or results in prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect or a medically important event. Adverse drug reaction refers to AE related to administered drug.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cabozantinib Monotherapy | Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib | 50.0 Percent of Adverse Drug Reactions |
| Cabozantinib + Nivolumab Combination Therapy | Percentage of Adverse Drug Reactions of Pancreatitis Leading to Dose Changes of Cabozantinib | 100.0 Percent of Adverse Drug Reactions |
Primary
Percentage of Adverse Events Leading to Dose Changes of Cabozantinib
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cabozantinib Monotherapy | Percentage of Adverse Events Leading to Dose Changes of Cabozantinib | 72.0 Percent of Adverse Events |
| Cabozantinib + Nivolumab Combination Therapy | Percentage of Adverse Events Leading to Dose Changes of Cabozantinib | 64.1 Percent of Adverse Events |
Secondary
Percentage of Participants Who Achieve or Maintain Any Best Response
Best response was assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best response was defined as the level of best response in assessment with complete response (CR), partial response (PR) during the observational period.
Time frame: Up to 26 weeks
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabozantinib Monotherapy | Percentage of Participants Who Achieve or Maintain Any Best Response | 106 Participants |
| Cabozantinib + Nivolumab Combination Therapy | Percentage of Participants Who Achieve or Maintain Any Best Response | 26 Participants |