Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SU011248 (sunitinib) | Experimental | Single-arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SU011248 (sunitinib) | Drug | 37.5 mg/day, oral, continuous daily dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects | Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Tumor Response | Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression. | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Stanford | California | 94305 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28410911 | Derived | de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21. | |
| 27238653 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
ECOG performance status definition 0=fully active, able to carry on all pre-disease activities without restriction 1= restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature (eg light house work or office work)
Patients must have failed 1 prior cytokine-based therapy for metastatic renal cell carcinoma and had to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AM Dose Sunitinib Malate (SU011248) | Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Time to Tumor Progression (TTP) | Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group). | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
| Progression Free Survival (PFS) | Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group). | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
| Overall Survival | Overall survival is time from the date of first dose of medication to the date of death due to any cause | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
| Summary of FACIT Fatigue Scale Overall Score | FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires. | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. |
| Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index | EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline. | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. |
| Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score | EQ-VAS score on the self-rated "thermometer" indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline). | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. |
| Las Vegas |
| Nevada |
| 89135 |
| United States |
| Pfizer Investigational Site | Villejuif | 94805 | France |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | München | 81664 | Germany |
| Pfizer Investigational Site | Thessaloniki | 56429 | Greece |
| Pfizer Investigational Site | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Pfizer Investigational Site | Lund | SE-221 85 | Sweden |
| Pfizer Investigational Site | Stockholm | 171 76 | Sweden |
| Pfizer Investigational Site | Sankt Gallen | CH-9007 | Switzerland |
| Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26. |
| 25577718 | Derived | Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7. |
| 19652072 | Derived | Escudier B, Roigas J, Gillessen S, Harmenberg U, Srinivas S, Mulder SF, Fountzilas G, Peschel C, Flodgren P, Maneval EC, Chen I, Vogelzang NJ. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009 Sep 1;27(25):4068-75. doi: 10.1200/JCO.2008.20.5476. Epub 2009 Aug 3. |
| FG001 | PM Dose Sunitinib Malate (SU011248) | Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AM Dose Sunitinib Malate (SU011248) | Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis. |
| BG001 | PM Dose Sunitinib Malate (SU011248) | Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects | Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | ITT; CR,PR calculated from patients with measurable disease at baseline+correct histological cancer type+ refractory to prior cytokine-based therapy n= 53,52 (AM,PM) | Posted | Number | participants | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Tumor Response | Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression. | ITT; DR time from start of 1st documentation of objective tumor response to 1st documentation of objective tumor progression or death & calculated for the subgroup of subjects with a confirmed objective tumor response. Descriptive statistics for responders who had an event. Total number responders n= 15,6(AM,PM). Response duration n=7,3(AM,PM). | Posted | Median | Full Range | weeks | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Tumor Progression (TTP) | Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group). | ITT;TTP calculated based on subgroup with baseline disease assessment, measurable disease at baseline, correct histological type and refractory to cytokine.Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. n=53,52(AM,PM). | Posted | Median | 95% Confidence Interval | weeks | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group). | ITT; Calculation based on subgroup of patients with baseline disease assessment, measurable disease at baseline, correct histological type and are refractory to cytokine. Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. N=53,52(AM,PM). | Posted | Median | 95% Confidence Interval | weeks | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is time from the date of first dose of medication to the date of death due to any cause | ITT; Patients who are alive at the time of analysis or who are lost to follow up are censored on the last date they were known to be alive. Estimates are based on the Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley method. n=54,53(AM,PM). | Posted | Median | 95% Confidence Interval | weeks | 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of FACIT Fatigue Scale Overall Score | FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires. | ITT; Results summarized by cohort & time point through Cycle 13 (the last cycle for which more than 3 subjects completed the questionnaire on either arm). If more than 50% of the items in the scale were answered, then missing items were imputed with the mean of the non-missing items scored at that visit. Outcome based on completed questionnaires. | Posted | Mean | Standard Deviation | score on scale | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index | EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline. | ITT | Posted | Median | Full Range | score on scale | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score | EQ-VAS score on the self-rated "thermometer" indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline). | ITT | Posted | Median | Full Range | score on scale | Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AM Dose Sunitinib Malate (SU011248) | Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria. | 21 | 54 | ||||
| EG001 | PM Dose Sunitinib Malate (SU011248) | Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria. | 20 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Subileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis haemorrhagic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Melaena | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis acute | Gastrointestinal disorders | Systematic Assessment |
| ||
| Salivary hypersecretion | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Gait disturbance | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Hypothermia | General disorders | Systematic Assessment |
| ||
| Multi-organ failure | General disorders | Systematic Assessment |
| ||
| Organ failure | General disorders | Systematic Assessment |
| ||
| Performance status decreased | General disorders | Systematic Assessment |
| ||
| Cholangitis acute | Hepatobiliary disorders | Systematic Assessment |
| ||
| Perirectal abscess | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Burn oesophageal | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Aspiration pleural cavity | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Bone lesion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteonecrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Brain oedema | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Depressed level of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Dysaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Paresis | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Systematic Assessment |
| ||
| Anuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Obstructive uropathy | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal haemorrhage | Renal and urinary disorders | Systematic Assessment |
| ||
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pleurodesis | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Glossodynia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gingival bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Oral herpes | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Vitamin B12 deficiency | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Ageusia | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hair colour changes | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperkeratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhage | Vascular disorders | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
Objective response rate required a sample size of 100 to test null hypothesis that true response rate was <=5% versus alternative hypothesis that true response rate was >=15% with 90% power and alpha level of 0.05. If number of OR> =11 null hypothesis that true response rate was <=5% could be rejected with a target α error rate of 0.05. |
| F distribution |
| Objective Response Rate |
| 11.5 |
| 95 |
| 4.4 |
| 23.4 |
| No |
| Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|