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A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUNITINIB MALATE. | Experimental | Sunitinib malate starting dose 37.5 mg daily continuous daily schedule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib malate | Drug | Sunitinib malate starting dose 37.5 mg daily continuous daily schedule |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Overall Confirmed Objective Response (OR) | OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DR) | Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Córdoba | Córdoba Province | X5000AAI | Argentina | ||
| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | 37.5 milligrams (mg) oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause |
| Time to Tumor Progression (TTP) | Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST. | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter |
| Progression-Free Survival (PFS) | Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7. | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death |
| 1-Year Survival | One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment. | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year |
| Trough Plasma Concentrations (Ctrough) of Sunitinib | Ctrough = the concentration prior to study drug administration. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib | Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib | Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough of SU-012662 (Sunitinib's Metabolite) | Ctrough = the concentration prior to study drug administration. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) | Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) | Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough of Total Drug (Sunitinib + SU-012662) | Ctrough = the concentration prior to study drug administration. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) | Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) | Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Ctrough Correlated With Serious Adverse Events (SAEs) | Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect. | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
| Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline | Baseline |
| VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD) | Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented. | Baseline (Cycle 1, Day 1) |
| VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) | Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented. | Baseline (Cycle 1, Day 1) |
| VEGF Ratio to Baseline at Each Time Point | VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline). | Baseline to Day 1 of Weeks 3 through 53 |
| VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) | Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD). | Baseline to Day 1 of Weeks 3 through 53 |
| VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) | Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD). | Baseline to Day 1 of Weeks 3 through 53 |
| Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline | Baseline |
| sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD) | Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented. | Baseline (Cycle 1, Day 1) |
| sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) | Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented. | Baseline (Cycle 1, Day 1) |
| sVEGFR2 Ratio to Baseline at Each Time Point | sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline). | Baseline to Day 1 of Weeks 3 through 53 |
| sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) | Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD). | Baseline to Day 1 of Weeks 3 through 53 |
| sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) | Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD). | Baseline to Day 1 of Weeks 3 through 53 |
| Patient-Assessed Fatigue | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only. | Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment) |
| Cancer Related Symptoms, Well-Being, and Concerns | FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only. | Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment) |
| Rosario |
| Santa Fe Province |
| (2000) |
| Argentina |
| Pfizer Investigational Site | Buenos Aires | 1431 | Argentina |
| Pfizer Investigational Site | Adelaide | South Australia | 5000 | Australia |
| Pfizer Investigational Site | Clayton | Victoria | 3168 | Australia |
| Pfizer Investigational Site | East Bentleigh | Victoria | 3165 | Australia |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01308-050 | Brazil |
| Pfizer Investigational Site | Guadalajara | Jalisco | 44280 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 120-752 | South Korea |
| Pfizer Investigational Site | Taichung | 407 | Taiwan |
| Pfizer Investigational Site | Tainan | 710 | Taiwan |
| Pfizer Investigational Site | Taipei | 112 | Taiwan |
| 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. |
| 21898376 | Derived | Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6. |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Subjects With Overall Confirmed Objective Response (OR) | OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis. | Posted | Number | participants | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter |
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| Secondary | Duration of Response (DR) | Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. | Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response. | Posted | Mean | 95% Confidence Interval | months | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause |
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| Secondary | Time to Tumor Progression (TTP) | Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST. | Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis. | Posted | Median | 95% Confidence Interval | months | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter |
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| Secondary | Progression-Free Survival (PFS) | Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7. | Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis. | Posted | Median | 95% Confidence Interval | months | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death |
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| Secondary | 1-Year Survival | One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment. | Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis. | Posted | Median | 95% Confidence Interval | percent chance of survival | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year |
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| Secondary | Trough Plasma Concentrations (Ctrough) of Sunitinib | Ctrough = the concentration prior to study drug administration. | Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point. | Posted | Mean | Standard Deviation | nanograms (ng)/milliliter (mL) | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib | Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ng/mL | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib | Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ng/mL | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough of SU-012662 (Sunitinib's Metabolite) | Ctrough = the concentration prior to study drug administration. | PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point. | Posted | Mean | Standard Deviation | ng/mL | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) | Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ng/mL | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) | Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ng/mL | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough of Total Drug (Sunitinib + SU-012662) | Ctrough = the concentration prior to study drug administration. | PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point. | Posted | Mean | Standard Deviation | ng/mL | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) | Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ng/mL | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) | Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ng/mL | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Ctrough Correlated With Serious Adverse Events (SAEs) | Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect. | Ctrough correlation analyses with SAEs were not performed due to low frequency of individual SAEs. | Posted | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 |
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| Secondary | Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline | Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. | Posted | Mean | Standard Deviation | picograms (pg)/mL | Baseline |
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| Secondary | VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD) | Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented. | Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline. | Posted | Median | Full Range | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) | Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented. | Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline. | Posted | Median | Full Range | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | VEGF Ratio to Baseline at Each Time Point | VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline). | Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline to Day 1 of Weeks 3 through 53 |
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| Secondary | VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) | Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD). | Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ratio | Baseline to Day 1 of Weeks 3 through 53 |
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| Secondary | VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) | Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD). | Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ratio | Baseline to Day 1 of Weeks 3 through 53 |
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| Secondary | Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline | Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline |
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| Secondary | sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD) | Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented. | Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline. | Posted | Median | Full Range | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) | Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented. | Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline. | Posted | Median | Full Range | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | sVEGFR2 Ratio to Baseline at Each Time Point | sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline). | Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline to Day 1 of Weeks 3 through 53 |
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| Secondary | sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) | Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD). | Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ratio | Baseline to Day 1 of Weeks 3 through 53 |
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| Secondary | sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) | Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD). | Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33. | Posted | Median | Full Range | ratio | Baseline to Day 1 of Weeks 3 through 53 |
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| Secondary | Patient-Assessed Fatigue | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only. | Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment) |
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| Secondary | Cancer Related Symptoms, Well-Being, and Concerns | FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only. | Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment) |
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Not provided
The same event may appear as both an adverse event (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.
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 | Sunitinib | 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities. | 45 | 119 | 117 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Eastern cooperative oncology group performance status worsened | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney 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 |
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
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| Cycle 1, Day 1 (CR or PR, n=39) |
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| Cycle 1, Day 1 (PD, n=16) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1, Day 1 (CR or PR, n=40) |
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| Cycle 1, Day 1 (PD, n=16) |
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