Renal Cell Carcinoma
Conditions
Keywords
Advanced renal cell Cancer, Non interventional study, Renal Cancer, Sutent, Metastatic, Advanced Renal Cell Carcinoma
Brief summary
The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.
Detailed description
The assignment of the patient to Sutent® treatment is not decided in advance by this noninterventional study protocol, but falls within current practice. The decision to prescribe Sutent® is clearly not driven by the decision to include the patient in this study.The sample size for this study is not based on statistical considerations. It is expected that a minimum of 100 patients will be enrolled in the study by the end of the first year and the data collected would be adequate to fulfill the observational objectives of the study.The study will be initiated at 10 sites across India during the 1st year. The study may be expanded with the addition of new sites during the 2nd year.
Interventions
OTHERNon Interventional
Sutent capsule, once daily administered per the locally approved product information.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with advanced renal cell cancer * Treatment naïve or cytokine refractory
Exclusion criteria
* Patients presenting with a known hypersensitivity to Sunitinib or its metabolites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose) | PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose) | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events | Baseline up to 1 year from start of first dose | An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented. |
| Number of Participants Who Required Management of Other Adverse Events | Baseline up to 1 year from start of first dose | An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Objective progression or relapse | 4 |
| Overall Study | Other | 2 |
Baseline characteristics
| Characteristic | Sunitinib |
|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 36 |
| serious Total, serious adverse events | 7 / 36 |
Outcome results
Primary
Progression Free Survival (PFS)
PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.
Time frame: Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)
Population: Data was not analyzed since PFS for all participants was censored either due to inadequate baseline assessments, absence of on-study disease assessment, or being on follow-up for progression.
Secondary
Number of Participants Who Required Management of Other Adverse Events
An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.
Time frame: Baseline up to 1 year from start of first dose
Population: Safety analysis set included all enrolled participants who started treatment with sunitinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | Number of Participants Who Required Management of Other Adverse Events | 20 participants |
Secondary
Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events
An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.
Time frame: Baseline up to 1 year from start of first dose
Population: Safety analysis set included all enrolled participants who started treatment with sunitinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events | Avoidance of Hot water for Cleaning Hands and Feet | 1 participants |
| Sunitinib | Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events | Dose Reduction | 1 participants |
| Sunitinib | Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events | Dose Interruption | 1 participants |
Secondary
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)
Population: Per protocol (PP) analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started sunitinib treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | Percentage of Participants With Objective Response (OR) | 0 percentage of participants |