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The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Surviving at One Year | Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment. | From start of treatment until 1 year or death |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02. | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death |
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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 | Los Angeles | California | 90048 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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During Part 1, subjects received carboplatin plus paclitaxel 172-225 mg/m2. Those same subjects were eligible for continuation in Part 2 where they received sunitinib 50 mg. 66 subjects continued in Part 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboplatin Plus Paclitaxel | Carboplatin Plus Paclitaxel 172-225 mg/m2 |
| FG001 | Sunitinib | Sunitinib 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
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| paclitaxel | Drug | 175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices. |
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| sunitinib | Drug | 50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol). |
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| Time to Tumor Progression (TTP) | TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02. | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) |
| Duration of Response (DR) | DR=time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a > = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.02. | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death |
| Number of Subjects With Overall Confirmed Objective Disease Response | Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). 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 until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) |
| Overall Survival (OS) | OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death - date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment. | From start of study treatment until death |
| Trough Plasma Concentration (Ctrough) of Sunitinib | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
| Ctrough of SU-012662 (Sunitinib's Metabolite) | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
| Ctrough of Total Drug (Sunitinib + SU-012662) | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
| Dose-Corrected Ctrough of Sunitinib | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
| Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
| Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
| Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline | Concentration of VEGFR3 at baseline. | Baseline (Cycle 1, Day 1) of Part 2 |
| VEGFR3 Ratio to Baseline at Each Time Point | VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline). | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| VEGF-C Concentration at Baseline | Concentration of VEGF-C at baseline. | Baseline (Cycle 1, Day 1) of Part 2 |
| VEGF-C Ratio to Baseline at Each Time Point | VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline). | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| Soluble E-Selectin at Baseline | Concentration of soluble E-Selectin at baseline. | Baseline (Cycle 1, Day 1) of Part 2 |
| Soluble E-Selectin Ratio to Baseline at Each Time Point | Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline). | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
| VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) of Part 2 |
| VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) of Part 2 |
| VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) of Part 2 |
| Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after Stratification by < or > = median changes from Baseline in VEGFR3 at each time point. | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point. | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point. | [Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from baseline in VEGFR3 at each time point. | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point. | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point. | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from Baseline in VEGFR3 at each time point. | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point. | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
| Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point. | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
| Immunohistochemical Staining of Paraffin Embedded Tumor Tissue | Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis. | Screening |
| Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib | A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized. | Within 7 days of Day 1 |
| Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1. | Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2 |
| Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1. | Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2 |
| Newark |
| Delaware |
| 19713 |
| United States |
| Pfizer Investigational Site | Newark | Delaware | 19718 | United States |
| Pfizer Investigational Site | Wilmington | Delaware | 19899 | United States |
| Pfizer Investigational Site | Maywood | Illinois | 60153 | United States |
| Pfizer Investigational Site | Jeffersonville | Indiana | 47130 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40202 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40217 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40241 | United States |
| Pfizer Investigational Site | Shelbyville | Kentucky | 40065 | United States |
| Pfizer Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Pfizer Investigational Site | Franklin | Tennessee | 37067 | United States |
| Pfizer Investigational Site | Gallatin | Tennessee | 37066 | United States |
| Pfizer Investigational Site | Hermitage | Tennessee | 37076 | United States |
| Pfizer Investigational Site | Lebanon | Tennessee | 37087 | United States |
| Pfizer Investigational Site | Murfreesboro | Tennessee | 37130 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203-1632 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37205 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37207 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37211 | United States |
| Pfizer Investigational Site | Smyrna | Tennessee | 37167 | United States |
| Pfizer Investigational Site | Burleson | Texas | 76028 | United States |
| Pfizer Investigational Site | Cleburne | Texas | 76031 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76104 | United States |
| Pfizer Investigational Site | Mineral Wells | Texas | 76067 | United States |
| Pfizer Investigational Site | Weatherford | Texas | 76086 | United States |
| Pfizer Investigational Site | Vancouver | British Columbia | V5Z4E6 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2L 4M1 | Canada |
| Pfizer Investigational Site | Caen | 14076 | France |
| Pfizer Investigational Site | Villejuif | 94805 | France |
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| NOT COMPLETED |
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| Part 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | First Carboplatin Plus Paclitaxel, Then Sunitinib | Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg |
| Units | Counts |
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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 | Proportion of Subjects Surviving at One Year | Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment. | Intent-to-treat (ITT) population = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin. | Posted | Number | proportion | From start of treatment until 1 year or death |
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| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02. | ITT | Posted | Median | 95% Confidence Interval | weeks | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death |
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| Secondary | Time to Tumor Progression (TTP) | TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02. | ITT | Posted | Median | 95% Confidence Interval | weeks | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) |
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| Secondary | Duration of Response (DR) | DR=time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a > = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.02. | ITT. DR was calculated for the subgroup of subjects with objective response. 23 subjects reported CR or PR response and were analyzed for DR. | Posted | Median | 95% Confidence Interval | weeks | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death |
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| Secondary | Number of Subjects With Overall Confirmed Objective Disease Response | Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). 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. | ITT | Posted | Number | participants | From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death - date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment. | ITT | Posted | Median | 95% Confidence Interval | months | From start of study treatment until death |
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| Secondary | Trough Plasma Concentration (Ctrough) of Sunitinib | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. | Pharmacokinetic (PK) = all subjects enrolled in the study who received at least 1 dose of carboplatin/paclitaxel or sunitinib. Subjects with plasma values below limit of quantification were excluded. | Posted | Mean | Standard Deviation | nanograms (ng)/milliliter (mL) | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
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| Secondary | Ctrough of SU-012662 (Sunitinib's Metabolite) | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. | PK. Subjects with plasma values below limit of quantification were excluded. | Posted | Mean | Standard Deviation | ng/mL | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
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| Secondary | Ctrough of Total Drug (Sunitinib + SU-012662) | Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval. | PK. Subjects with plasma values below limit of quantification were excluded. | Posted | Mean | Standard Deviation | ng/mL | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
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| Secondary | Dose-Corrected Ctrough of Sunitinib | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. | PK. Subjects with plasma values below limit of quantification were excluded. | Posted | Mean | Standard Deviation | ng/mL | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
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| Secondary | Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. | PK. Subjects with plasma values below limit of quantification were excluded. | Posted | Mean | Standard Deviation | ng/mL | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
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| Secondary | Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) | Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included. | PK. Subjects with plasma values below limit of quantification were excluded. | Posted | Mean | Standard Deviation | ng/mL | predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2 |
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| Secondary | Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline | Concentration of VEGFR3 at baseline. | Modified ITT population (MITT) = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin and at least 1 dose of Sunitinib. | Posted | Mean | Standard Deviation | picograms (pg)/milliliter (mL) | Baseline (Cycle 1, Day 1) of Part 2 |
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| Secondary | VEGFR3 Ratio to Baseline at Each Time Point | VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline). | MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
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| Secondary | VEGF-C Concentration at Baseline | Concentration of VEGF-C at baseline. | MITT. Number of participants analyzed = number of subjects with VEGF-C data at Baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Cycle 1, Day 1) of Part 2 |
|
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| Secondary | VEGF-C Ratio to Baseline at Each Time Point | VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline). | MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
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| Secondary | Soluble E-Selectin at Baseline | Concentration of soluble E-Selectin at baseline. | MITT. Number of participants analyzed = number of subjects with soluble E-Selectin data at Baseline. | Posted | Mean | Standard Deviation | nanograms (ng)/mL | Baseline (Cycle 1, Day 1) of Part 2 |
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| Secondary | Soluble E-Selectin Ratio to Baseline at Each Time Point | Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline). | MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. At Cycle 4, Day 28, median and/or standard deviation were not able to be estimated. | Posted | Mean | Standard Deviation | ratio | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
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| Secondary | VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). | MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) of Part 2 |
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| Secondary | VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28. | Posted | Number | ratio | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
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| Secondary | VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). | MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) of Part 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28. | Posted | Number | ratio | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality). | MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) of Part 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) | Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 4, Day 28 and Cycle 5, Day 28. | Posted | Number | ratio | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
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| Secondary | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after Stratification by < or > = median changes from Baseline in VEGFR3 at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | weeks | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | weeks | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | weeks | [Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
|
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| Secondary | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from baseline in VEGFR3 at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | weeks | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint), and Cycle 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | weeks | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
|
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| Secondary | Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline | TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | weeks | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
|
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| Secondary | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline | OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from Baseline in VEGFR3 at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | months | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
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| Secondary | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline | OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | months | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2 |
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| Secondary | Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline | OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point. | MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), Cycle 4, Day 28 (< median cutpoint, > = median cutpoint)and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated. | Posted | Median | 95% Confidence Interval | months | Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2 |
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| Secondary | Immunohistochemical Staining of Paraffin Embedded Tumor Tissue | Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis. | Samples were collected and stained from a subset of subjects. Due to the small sample size, no correlative analyses with clinical outcome were conducted. | Posted | Number | samples | Screening |
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| Secondary | Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib | A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized. | c-Kit, Flt-3 and c-Fms to safety of Sunitinib samples were collected and analyzed. However, there was no statistics performed since power was insufficient. | Posted | Number | pg/mL | Within 7 days of Day 1 |
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| Secondary | Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) | EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1. | ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability. | Posted | Mean | Standard Error | scores on a scale | Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2 |
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| Secondary | Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) | QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1. | ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability. | Posted | Mean | Standard Error | scores on a scale | Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2 |
|
|
Not provided
Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
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 | Carboplatin Plus Paclitaxel 172-225 mg/m2 (Part 1) | 29 | 84 | 82 | 84 | |||
| EG001 | Sunitinib 50 mg (Part 2) | 29 | 66 | 60 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebellar syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Phlebitis superficial | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine 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 |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chills | 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 peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Weight 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 |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric 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 |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal discomfort | 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 |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin exfoliation | 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 < 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 information 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 |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Other |
|
| Laboratory Abnormality |
|
| Ongoing |
|
| No |
| Superiority or Other |
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1, Day 28 (n=51) |
| |||||
| Cycle 2, Day 28 (n=36) |
| |||||
| Cycle 3, Day 28 (n=16) |
| |||||
| Cycle 5, Day 28 (n=6) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1, Day 28 (n=51) |
| |||||
| Cycle 2, Day 28 (n=36) |
| |||||
| Cycle 3, Day 28 (n=16) |
| |||||
| Cycle 5, Day 28 (n=6) |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1, Day 28 (n=46) |
| |||||
| Cycle 2, Day 1 (n=40) |
| |||||
| Cycle 2, Day 28 (n=29) |
| |||||
| Cycle 3, Day 1 (n=21) |
| |||||
| Cycle 3, Day 28 (n=12) |
| |||||
| Cycle 5, Day 28 (n=4) |
|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1, Day 28 (n=46) |
| |||||
| Cycle 2, Day 1 (n=39) |
| |||||
| Cycle 2, Day 28 (n=30) |
| |||||
| Cycle 3, Day 1 (n=20) |
| |||||
| Cycle 3, Day 28 (n=12) |
| |||||
| Cycle 5, Day 28 (n=4) |
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| Title |
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| Denominators |
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| Categories |
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