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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Non Interventional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Interventional | Other | Sutent capsule, once daily administered per the locally approved product information. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with advanced renal cell cancer in the treatment naïve or cytokine refractory settings prescribed Sutent® will be eligible for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Jaipur | Jaipur | 302006 | India | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | 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. | Posted | Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose) |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15.1 | Non-systematic Assessment |
Relatively small sample size might limit any useful interpretation and applicability of data for larger populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| 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. | 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. | Baseline up to 1 year from start of first dose |
| Bangalore |
| Karnataka |
| 560 027 |
| India |
| Pfizer Investigational Site | Mumbai | Maharashtra | 400014 | India |
| Pfizer Investigational Site | New Delhi | National Capital Territory of Delhi | 110 085 | India |
| Pfizer Investigational Site | Chandigard | Punjab | 141402 | India |
| Pfizer Investigational Site | Kolkata | West Bengal | 700 106 | India |
| Pfizer Investigational Site | Delhi | 110 060 | India |
| Objective progression or relapse |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose) |
|
|
|
| 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. | Safety analysis set included all enrolled participants who started treatment with sunitinib. | Posted | Number | participants | Baseline up to 1 year from start of first dose |
|
|
|
| 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. | Safety analysis set included all enrolled participants who started treatment with sunitinib. | Posted | Number | participants | Baseline up to 1 year from start of first dose |
|
|
|
| 7 |
| 36 |
| 20 |
| 36 |
| Cardiopulmonary failure | Cardiac disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Diabetic foot infection | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA v15.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Adverse event | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v15.1 | Non-systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Blood creatinine | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Neutrophil count | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Platelet count | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hyponatraemia | Investigations | MedDRA v15.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.1 | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v15.1 | Non-systematic Assessment |
|
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 |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|