An observational study in Renal Cell Carcinoma, sponsored by Pfizer. Completed at 7 sites in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-20.
Sponsored by Pfizer · Observational
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.
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.
1,964 studies on the registry are indexed under Carcinoma, Renal Cell; 377 are open to participants now.
This study's enrollment of 36 is below the median of 146 across 360 observational studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with advanced renal cell cancer in the treatment naïve or cytokine refractory settings prescribed Sutent® will be eligible for the study.
Exclusion Criteria:
Non Interventional
Other: Non Interventional
Sutent capsule, once daily administered per the locally approved product information.
Also known as: Observational
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)
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)
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
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
| Milestone | Sunitinib |
|---|---|
| Started | 36 |
| Completed | 15 |
| Not completed | 21 |
| Withdrew: Death | 2 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Adverse event | 3 |
| Withdrew: Objective progression or relapse | 4 |
| Withdrew: Other | 2 |
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.
No measurements were reported for this outcome.
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.
| percentage of participants | Sunitinib |
|---|---|
| Percentage of Participants With Objective Response (OR) | 0 (0.0 to 60.2) |
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.
| participants | Sunitinib |
|---|---|
| Dose Reduction | 1 |
| Dose Interruption | 1 |
| Avoidance of Hot water for Cleaning Hands and Feet | 1 |
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.
| participants | Sunitinib |
|---|---|
| Number of Participants Who Required Management of Other Adverse Events | 20 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib | — | 7/36 (19.4%) | 20/36 (55.6%) |
| Event | Sunitinib |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 1/36 |
| Cardiopulmonary failureCardiac disorders | 1/36 |
| Myocardial ischaemiaCardiac disorders | 1/36 |
| ConstipationGastrointestinal disorders | 1/36 |
| MelaenaGastrointestinal disorders | 1/36 |
| StomatitisGastrointestinal disorders | 1/36 |
| AstheniaGeneral disorders | 1/36 |
| Disease progressionGeneral disorders | 1/36 |
| Diabetic foot infectionInfections and infestations | 1/36 |
| Post procedural dischargeInjury, poisoning and procedural complications | 1/36 |
| Event | Sunitinib |
|---|---|
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 5/36 |
| HyperbilirubinaemiaHepatobiliary disorders | 4/36 |
| Weight decreasedInvestigations | 4/36 |
| Decreased appetiteMetabolism and nutrition disorders | 4/36 |
| HypothyroidismEndocrine disorders | 3/36 |
| AstheniaGeneral disorders | 3/36 |
| PyrexiaGeneral disorders | 3/36 |
| Aspartate aminotransferaseInvestigations | 3/36 |
| HyponatraemiaInvestigations | 3/36 |
| Back painMusculoskeletal and connective tissue disorders | 3/36 |
| Age, Continuous(years) | Sunitinib |
|---|---|
| Mean | 57.8 ± 9.5 |
| Sex: Female, Male(Participants) | Sunitinib |
|---|---|
| Female | 5 |
| Male | 31 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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